Trial Outcomes & Findings for Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia (NCT NCT00716274)
NCT ID: NCT00716274
Last Updated: 2022-11-04
Results Overview
Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response)
COMPLETED
PHASE4
110 participants
Baseline, 16 Weeks
2022-11-04
Participant Flow
Participants were randomized to either atomoxetine or placebo during study period II. Placebo participants were then assigned to atomoxetine in study period III. Atomoxetine participants were re-randomized to atomoxetine or placebo in study period III. Participants assigned to the healthy control group did not receive any study drug.
Participant milestones
| Measure |
Atomoxetine
Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III).
|
Placebo
Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
ATX/ATX
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
Healthy Participants
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study.
|
|---|---|---|---|---|---|---|
|
Study Period II (16-Weeks)
STARTED
|
45
|
44
|
0
|
0
|
0
|
21
|
|
Study Period II (16-Weeks)
COMPLETED
|
36
|
35
|
0
|
0
|
0
|
19
|
|
Study Period II (16-Weeks)
NOT COMPLETED
|
9
|
9
|
0
|
0
|
0
|
2
|
|
Study Period III (16-Weeks)
STARTED
|
0
|
0
|
18
|
18
|
35
|
19
|
|
Study Period III (16-Weeks)
COMPLETED
|
0
|
0
|
16
|
17
|
32
|
19
|
|
Study Period III (16-Weeks)
NOT COMPLETED
|
0
|
0
|
2
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
Atomoxetine
Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III).
|
Placebo
Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
ATX/ATX
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
Healthy Participants
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study.
|
|---|---|---|---|---|---|---|
|
Study Period II (16-Weeks)
Entry Criteria Not Met
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Study Period II (16-Weeks)
Protocol Violation
|
0
|
3
|
0
|
0
|
0
|
1
|
|
Study Period II (16-Weeks)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Study Period II (16-Weeks)
Physician Decision
|
3
|
1
|
0
|
0
|
0
|
1
|
|
Study Period II (16-Weeks)
Parent/Caregiver Decision
|
3
|
3
|
0
|
0
|
0
|
0
|
|
Study Period II (16-Weeks)
Lost to Follow-up
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Study Period III (16-Weeks)
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Study Period III (16-Weeks)
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Study Period III (16-Weeks)
Parent Caregiver Decision
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Study Period III (16-Weeks)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=45 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
|
Placebo
n=44 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
Healthy Participants
n=21 Participants
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.2 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
12.1 years
STANDARD_DEVIATION 1.90 • n=7 Participants
|
12.4 years
STANDARD_DEVIATION 2.05 • n=5 Participants
|
12.20 years
STANDARD_DEVIATION 1.92 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All participants who received study drug, had Dyslexia Alone and had fMRI data.
Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response)
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=10 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Semantic-category: Left Interior Temporal Gyrus
|
-0.061 Change-from-baseline (BOLD response)
Standard Deviation 0.120
|
0.010 Change-from-baseline (BOLD response)
Standard Deviation 0.075
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Semantic-category: Left Inferior Frontal Gyrus
|
-0.056 Change-from-baseline (BOLD response)
Standard Deviation 0.125
|
-0.033 Change-from-baseline (BOLD response)
Standard Deviation 0.118
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Semantic-category: Left Medial Temporal Gyrus
|
-0.038 Change-from-baseline (BOLD response)
Standard Deviation 0.153
|
-0.006 Change-from-baseline (BOLD response)
Standard Deviation 0.053
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Semantic-category: Left Temporo-parietal Region
|
-0.073 Change-from-baseline (BOLD response)
Standard Deviation 0.124
|
-0.037 Change-from-baseline (BOLD response)
Standard Deviation 0.100
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Semantic-category: Right Inferior Frontal Gyrus
|
0.019 Change-from-baseline (BOLD response)
Standard Deviation 0.156
|
0.018 Change-from-baseline (BOLD response)
Standard Deviation 0.147
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Semantic-category: Right Interior Temporal Gyrus
|
0.002 Change-from-baseline (BOLD response)
Standard Deviation 0.217
|
0.058 Change-from-baseline (BOLD response)
Standard Deviation 0.161
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Semantic-category: Right Medial Temporal Gyrus
|
-0.014 Change-from-baseline (BOLD response)
Standard Deviation 0.181
|
0.071 Change-from-baseline (BOLD response)
Standard Deviation 0.091
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Semantic-category: Right Temporo-parietal Region
|
-0.015 Change-from-baseline (BOLD response)
Standard Deviation 0.145
|
0.076 Change-from-baseline (BOLD response)
Standard Deviation 0.114
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Pseudoword Rhyming: Left Inferior Frontal Gyrus
|
0.012 Change-from-baseline (BOLD response)
Standard Deviation 0.200
|
0.020 Change-from-baseline (BOLD response)
Standard Deviation 0.147
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Pseudoword Rhyming: Left Interior Temporal Gyrus
|
-0.062 Change-from-baseline (BOLD response)
Standard Deviation 0.200
|
-0.003 Change-from-baseline (BOLD response)
Standard Deviation 0.109
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Pseudoword Rhyming: Left Medial Temporal Gyrus
|
0.005 Change-from-baseline (BOLD response)
Standard Deviation 0.253
|
0.024 Change-from-baseline (BOLD response)
Standard Deviation 0.133
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Pseudoword Rhyming: Left Temporo-parietal Region
|
-0.026 Change-from-baseline (BOLD response)
Standard Deviation 0.243
|
-0.012 Change-from-baseline (BOLD response)
Standard Deviation 0.115
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Pseudoword Rhyming: Right Inferior Frontal Gyrus
|
-0.017 Change-from-baseline (BOLD response)
Standard Deviation 0.304
|
0.024 Change-from-baseline (BOLD response)
Standard Deviation 0.187
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Pseudoword Rhyming: Right Interior Temporal Gyrus
|
0.013 Change-from-baseline (BOLD response)
Standard Deviation 0.266
|
0.103 Change-from-baseline (BOLD response)
Standard Deviation 0.174
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Pseudoword Rhyming: Right Medial Temporal Gyrus
|
0.039 Change-from-baseline (BOLD response)
Standard Deviation 0.250
|
0.009 Change-from-baseline (BOLD response)
Standard Deviation 0.098
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category)
Pseudoword Rhyming: Temporo-parietal Region
|
0.011 Change-from-baseline (BOLD response)
Standard Deviation 0.296
|
0.087 Change-from-baseline (BOLD response)
Standard Deviation 0.170
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 WeeksPopulation: Stroop Tasks data were not collected.
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All participants who received study drug, had ADHD or ADHD + Dyslexia and had fMRI data.
Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response)
Outcome measures
| Measure |
Atomoxetine
n=11 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=12 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Semantic-category: Right Inferior Frontal Gyrus
|
0.065 Change-from-baseline (BOLD response)
Standard Deviation 0.095
|
-0.016 Change-from-baseline (BOLD response)
Standard Deviation 0.152
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Semantic-category: Right Interior Temporal Gyrus
|
0.008 Change-from-baseline (BOLD response)
Standard Deviation 0.150
|
0.015 Change-from-baseline (BOLD response)
Standard Deviation 0.222
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Semantic-category: Right Medial Temporal Gyrus
|
-0.046 Change-from-baseline (BOLD response)
Standard Deviation 0.169
|
-0.045 Change-from-baseline (BOLD response)
Standard Deviation 0.168
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Semantic-category: Right Temporo-parietal Region
|
0.053 Change-from-baseline (BOLD response)
Standard Deviation 0.120
|
-0.035 Change-from-baseline (BOLD response)
Standard Deviation 0.153
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Pseudoword Rhyming: Left Inferior Frontal Gyrus
|
0.081 Change-from-baseline (BOLD response)
Standard Deviation 0.245
|
0.005 Change-from-baseline (BOLD response)
Standard Deviation 0.151
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Pseudoword Rhyming: Left Interior Temporal Gyrus
|
0.142 Change-from-baseline (BOLD response)
Standard Deviation 0.370
|
0.047 Change-from-baseline (BOLD response)
Standard Deviation 0.202
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Pseudoword Rhyming: Left Medial Temporal Gyrus
|
0.091 Change-from-baseline (BOLD response)
Standard Deviation 0.387
|
0.042 Change-from-baseline (BOLD response)
Standard Deviation 0.184
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Pseudoword Rhyming: Left Temporo-parietal Region
|
0.096 Change-from-baseline (BOLD response)
Standard Deviation 0.321
|
0.012 Change-from-baseline (BOLD response)
Standard Deviation 0.184
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Pseudoword Rhyming: Right Inferior Frontal Gyrus
|
0.069 Change-from-baseline (BOLD response)
Standard Deviation 0.291
|
-0.006 Change-from-baseline (BOLD response)
Standard Deviation 0.111
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Semantic-category: Left Inferior Frontal Gyrus
|
0.077 Change-from-baseline (BOLD response)
Standard Deviation 0.085
|
-0.038 Change-from-baseline (BOLD response)
Standard Deviation 0.141
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Semantic-category: Left Interior Temporal Gyrus
|
0.079 Change-from-baseline (BOLD response)
Standard Deviation 0.128
|
-0.1 Change-from-baseline (BOLD response)
Standard Deviation 0.252
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Semantic-category: Left Medial Temporal Gyrus
|
0.038 Change-from-baseline (BOLD response)
Standard Deviation 0.105
|
-0.037 Change-from-baseline (BOLD response)
Standard Deviation 0.208
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Semantic-category: Left Temporo-parietal Region
|
0.079 Change-from-baseline (BOLD response)
Standard Deviation 0.065
|
-0.096 Change-from-baseline (BOLD response)
Standard Deviation 0.187
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Pseudoword Rhyming: Right Interior Temporal Gyrus
|
0.114 Change-from-baseline (BOLD response)
Standard Deviation 0.453
|
0.047 Change-from-baseline (BOLD response)
Standard Deviation 0.164
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Pseudoword Rhyming: Right Medial Temporal Gyrus
|
0.080 Change-from-baseline (BOLD response)
Standard Deviation 0.470
|
0.002 Change-from-baseline (BOLD response)
Standard Deviation 0.203
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD+Dyslexia, Pseudoword Rhyming: Temporo-parietal Region
|
0.078 Change-from-baseline (BOLD response)
Standard Deviation 0.308
|
-0.026 Change-from-baseline (BOLD response)
Standard Deviation 0.147
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Semantic-category: Left Inferior Frontal Gyrus
|
0.013 Change-from-baseline (BOLD response)
Standard Deviation 0.166
|
-0.057 Change-from-baseline (BOLD response)
Standard Deviation 0.120
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Semantic-category: Left Interior Temporal Gyrus
|
-0.024 Change-from-baseline (BOLD response)
Standard Deviation 0.083
|
-0.035 Change-from-baseline (BOLD response)
Standard Deviation 0.105
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Semantic-category: Left Medial Temporal Gyrus
|
-0.002 Change-from-baseline (BOLD response)
Standard Deviation 0.168
|
-0.047 Change-from-baseline (BOLD response)
Standard Deviation 0.166
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Semantic-category: Left Temporo-parietal Region
|
-0.013 Change-from-baseline (BOLD response)
Standard Deviation 0.131
|
-0.064 Change-from-baseline (BOLD response)
Standard Deviation 0.124
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Semantic-category: Right Inferior Frontal Gyrus
|
-0.074 Change-from-baseline (BOLD response)
Standard Deviation 0.141
|
-0.030 Change-from-baseline (BOLD response)
Standard Deviation 0.211
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Semantic-category: Right Interior Temporal Gyrus
|
0.052 Change-from-baseline (BOLD response)
Standard Deviation 0.236
|
-0.100 Change-from-baseline (BOLD response)
Standard Deviation 0.141
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Semantic-category: Right Medial Temporal Gyrus
|
-0.039 Change-from-baseline (BOLD response)
Standard Deviation 0.240
|
0.019 Change-from-baseline (BOLD response)
Standard Deviation 0.211
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Semantic-category: Right Temporo-parietal Region
|
0.034 Change-from-baseline (BOLD response)
Standard Deviation 0.124
|
-0.101 Change-from-baseline (BOLD response)
Standard Deviation 0.129
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Pseudoword Rhyming: Left Inferior Frontal Gyrus
|
-0.029 Change-from-baseline (BOLD response)
Standard Deviation 0.153
|
0.101 Change-from-baseline (BOLD response)
Standard Deviation 0.203
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Pseudoword Rhyming: Left Interior Temporal Gyrus
|
-0.012 Change-from-baseline (BOLD response)
Standard Deviation 0.194
|
0.063 Change-from-baseline (BOLD response)
Standard Deviation 0.240
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Pseudoword Rhyming: Left Medial Temporal Gyrus
|
-0.030 Change-from-baseline (BOLD response)
Standard Deviation 0.137
|
0.058 Change-from-baseline (BOLD response)
Standard Deviation 0.260
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Pseudoword Rhyming: Left Temporo-parietal Region
|
-0.013 Change-from-baseline (BOLD response)
Standard Deviation 0.172
|
0.029 Change-from-baseline (BOLD response)
Standard Deviation 0.195
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Pseudoword Rhyming: Right Inferior Frontal Gyrus
|
0.005 Change-from-baseline (BOLD response)
Standard Deviation 0.139
|
0.088 Change-from-baseline (BOLD response)
Standard Deviation 0.289
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Pseudoword Rhyming: Right Interior Temporal Gyrus
|
-0.003 Change-from-baseline (BOLD response)
Standard Deviation 0.226
|
0.043 Change-from-baseline (BOLD response)
Standard Deviation 0.246
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Pseudoword Rhyming: Right Medial Temporal Gyrus
|
0.007 Change-from-baseline (BOLD response)
Standard Deviation 0.116
|
-0.011 Change-from-baseline (BOLD response)
Standard Deviation 0.402
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
ADHD Only, Pseudoword Rhyming: Temporo-parietal Region
|
-0.016 Change-from-baseline (BOLD response)
Standard Deviation 0.204
|
0.046 Change-from-baseline (BOLD response)
Standard Deviation 0.149
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 WeeksPopulation: Stroop Tasks data were not collected.
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=23 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=23 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia
ADHD + Dyslexia
|
-11.04 units on a scale
Standard Error 2.518
|
-7.53 units on a scale
Standard Error 2.155
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia
ADHD Alone
|
-13.85 units on a scale
Standard Error 2.323
|
-1.63 units on a scale
Standard Error 2.588
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=13 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone
|
-3.57 units on a scale
Standard Error 4.84
|
2.92 units on a scale
Standard Error 4.75
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=13 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone
|
-2.81 units on a scale
Standard Error 3.87
|
2.25 units on a scale
Standard Error 3.85
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, "ADD possible but not likely". 40-54 equate to, "ADD probable but not certain". 55-120 equate to, "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=23 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=22 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD + Dyslexia
|
-6.91 units on a scale
Standard Error 4.689
|
-4.29 units on a scale
Standard Error 4.128
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD Alone
|
-9.05 units on a scale
Standard Error 5.515
|
-1.85 units on a scale
Standard Error 6.695
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who had a WJ III baseline and post-baseline measurement.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=13 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Letter Word Identification
|
0.88 units on a scale
Standard Error 1.12
|
2.77 units on a scale
Standard Error 1.10
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Word Attack Score
|
0.48 units on a scale
Standard Error 1.71
|
2.53 units on a scale
Standard Error 1.68
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Reading Vocabulary Score
|
1.04 units on a scale
Standard Error 1.81
|
-1.73 units on a scale
Standard Error 1.75
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Reading Fluency Score
|
0.13 units on a scale
Standard Error 1.59
|
-1.06 units on a scale
Standard Error 1.53
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Reading Comprehension Score
|
2.38 units on a scale
Standard Error 1.81
|
-1.03 units on a scale
Standard Error 1.74
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Spelling Score
|
0.89 units on a scale
Standard Error 1.50
|
-0.36 units on a scale
Standard Error 1.48
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Spelling of Sounds Score
|
3.11 units on a scale
Standard Error 1.48
|
3.59 units on a scale
Standard Error 1.43
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Basic Reading Skills Score
|
0.99 units on a scale
Standard Error 1.15
|
2.13 units on a scale
Standard Error 1.15
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Passage Comprehension
|
2.80 units on a scale
Standard Error 2.03
|
-0.20 units on a scale
Standard Error 1.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who had a baseline and post-baseline WJ III measurement.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=13 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Basic Reading Skills
|
2.53 units on a scale
Standard Error 1.05
|
-0.21 units on a scale
Standard Error 1.01
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Reading Fluency
|
-3.41 units on a scale
Standard Error 2.16
|
2.61 units on a scale
Standard Error 2.06
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Reading Comprehension
|
2.02 units on a scale
Standard Error 1.63
|
0.80 units on a scale
Standard Error 1.56
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Letter Word Identification
|
1.71 units on a scale
Standard Error 1.75
|
-0.90 units on a scale
Standard Error 1.69
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Word Attack Score
|
2.65 units on a scale
Standard Error 1.13
|
0.71 units on a scale
Standard Error 1.07
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Reading Vocabulary
|
0.69 units on a scale
Standard Error 1.89
|
2.80 units on a scale
Standard Error 1.77
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Spelling
|
-1.36 units on a scale
Standard Error 2.25
|
-2.59 units on a scale
Standard Error 2.19
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Spelling of Sounds
|
8.42 units on a scale
Standard Error 1.76
|
5.02 units on a scale
Standard Error 1.67
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Passage Comprehension Score
|
2.65 units on a scale
Standard Error 1.71
|
-1.01 units on a scale
Standard Error 1.65
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who had a baseline and post-baseline WJ III measurement.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=13 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Reading Fluency
|
-2.70 units on a scale
Standard Error 1.58
|
-4.98 units on a scale
Standard Error 1.81
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Spelling of Sounds
|
5.90 units on a scale
Standard Error 3.51
|
0.57 units on a scale
Standard Error 4.04
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Reading Comprehension
|
-2.92 units on a scale
Standard Error 2.39
|
-1.40 units on a scale
Standard Error 2.77
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Letter Word Identification
|
2.60 units on a scale
Standard Error 1.77
|
0.46 units on a scale
Standard Error 2.08
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Word Attack Score
|
-1.60 units on a scale
Standard Error 1.56
|
0.08 units on a scale
Standard Error 1.78
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Reading Vocabulary
|
-1.15 units on a scale
Standard Error 2.65
|
-1.48 units on a scale
Standard Error 3.23
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Spelling
|
4.30 units on a scale
Standard Error 1.20
|
3.62 units on a scale
Standard Error 1.39
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Basic Reading Skills
|
0.86 units on a scale
Standard Error 1.42
|
0.48 units on a scale
Standard Error 1.65
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Passage Comprehension Score
|
-4.10 units on a scale
Standard Error 2.36
|
-1.80 units on a scale
Standard Error 2.70
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=13 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone
Phonological Awareness
|
4.01 units on a scale
Standard Deviation 4.81
|
2.69 units on a scale
Standard Deviation 1.91
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone
Phonological Memory
|
5.62 units on a scale
Standard Deviation 1.82
|
0.62 units on a scale
Standard Deviation 1.75
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone
Rapid Naming Score
|
0.19 units on a scale
Standard Deviation 2.31
|
-1.00 units on a scale
Standard Deviation 2.23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=12 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=15 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia
Phonological Awareness
|
4.60 units on a scale
Standard Deviation 1.74
|
1.35 units on a scale
Standard Deviation 1.66
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia
Phonological Memory
|
2.33 units on a scale
Standard Deviation 2.49
|
3.43 units on a scale
Standard Deviation 2.39
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia
Rapid Naming Score
|
-0.71 units on a scale
Standard Deviation 2.46
|
0.21 units on a scale
Standard Deviation 2.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=12 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=9 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone
Phonological Awareness
|
3.66 units on a scale
Standard Deviation 2.10
|
7.00 units on a scale
Standard Deviation 2.57
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone
Phonological Memory
|
3.70 units on a scale
Standard Deviation 2.61
|
3.48 units on a scale
Standard Deviation 2.98
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone
Rapid Naming Score
|
2.36 units on a scale
Standard Deviation 3.01
|
1.63 units on a scale
Standard Deviation 3.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=12 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
Oral Reading Quotient
|
2.30 units on a scale
Standard Error 2.69
|
-2.66 units on a scale
Standard Error 2.72
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
Oral Reading Rate
|
0.24 units on a scale
Standard Error 0.27
|
-0.44 units on a scale
Standard Error 0.27
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
Accuracy
|
-0.10 units on a scale
Standard Error 0.46
|
-0.72 units on a scale
Standard Error 0.47
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
Fluency
|
-0.17 units on a scale
Standard Error 0.42
|
-0.65 units on a scale
Standard Error 0.42
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
Reading Comprehension
|
0.89 units on a scale
Standard Error 0.77
|
-0.29 units on a scale
Standard Error 0.77
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=12 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=15 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Fluency
|
-1.66 units on a scale
Standard Error 0.34
|
-0.81 units on a scale
Standard Error 0.31
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Oral Reading Rate
|
-0.59 units on a scale
Standard Error 0.40
|
-0.45 units on a scale
Standard Error 0.37
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Accuracy
|
-1.77 units on a scale
Standard Error 0.53
|
-1.02 units on a scale
Standard Error 0.47
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Reading Comprehension
|
-2.46 units on a scale
Standard Error 0.67
|
-1.55 units on a scale
Standard Error 0.62
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Oral Reading Quotient
|
-14.01 units on a scale
Standard Error 4.10
|
-12.23 units on a scale
Standard Error 3.40
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=12 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=9 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Fluency
|
0.72 units on a scale
Standard Error 0.35
|
0.94 units on a scale
Standard Error 0.40
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Oral Reading Rate
|
0.80 units on a scale
Standard Error 0.42
|
0.97 units on a scale
Standard Error 0.48
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Accuracy
|
0.46 units on a scale
Standard Error 0.35
|
-0.17 units on a scale
Standard Error 0.40
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Reading Comprehension
|
-0.96 units on a scale
Standard Error 0.59
|
0.79 units on a scale
Standard Error 0.70
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Oral Reading Quotient
|
-0.74 units on a scale
Standard Error 2.12
|
5.63 units on a scale
Standard Error 2.46
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=14 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=12 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone
|
2.21 units on a scale
Standard Error 1.345
|
-0.17 units on a scale
Standard Error 1.471
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=26 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=28 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD + Dyslexia
|
0.59 units on a scale
Standard Error 1.435
|
1.18 units on a scale
Standard Error 1.231
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD Alone
|
4.98 units on a scale
Standard Error 1.611
|
4.69 units on a scale
Standard Error 1.844
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=14 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=13 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Digit Recall Score
|
0.74 units on a scale
Standard Error 1.25
|
0.94 units on a scale
Standard Error 1.26
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Counting Recall Score
|
1.83 units on a scale
Standard Error 0.85
|
0.18 units on a scale
Standard Error 0.88
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Word List Matching Score
|
0.34 units on a scale
Standard Error 2.15
|
0.97 units on a scale
Standard Error 2.12
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Word List Recall Score
|
0.61 units on a scale
Standard Error 0.81
|
0.50 units on a scale
Standard Error 0.83
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Nonword List Recall Score
|
-0.10 units on a scale
Standard Error 0.68
|
0.17 units on a scale
Standard Error 0.69
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Block Recall Score
|
0.59 units on a scale
Standard Error 1.23
|
0.82 units on a scale
Standard Error 1.25
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Mazes Memory Score
|
-1.05 units on a scale
Standard Error 1.87
|
-2.96 units on a scale
Standard Error 1.91
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Listening Recall Score
|
1.41 units on a scale
Standard Error 0.82
|
-0.52 units on a scale
Standard Error 0.84
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Backward Digit Recall Score
|
-0.28 units on a scale
Standard Error 1.52
|
0.65 units on a scale
Standard Error 1.55
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=12 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=16 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Digit Recall
|
-0.64 units on a scale
Standard Error 1.04
|
1.03 units on a scale
Standard Error 0.93
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Mazes Memory Score
|
3.08 units on a scale
Standard Error 1.34
|
-1.01 units on a scale
Standard Error 1.22
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Listening Recall
|
-0.48 units on a scale
Standard Error 0.75
|
2.16 units on a scale
Standard Error 0.68
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Word List Matching
|
-0.02 units on a scale
Standard Error 1.90
|
-0.78 units on a scale
Standard Error 1.72
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Word List Recall
|
-0.78 units on a scale
Standard Error 0.77
|
0.80 units on a scale
Standard Error 0.70
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
NonWord
|
0.12 units on a scale
Standard Error 0.32
|
1.12 units on a scale
Standard Error 0.29
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Block Recall
|
-1.71 units on a scale
Standard Error 0.83
|
0.75 units on a scale
Standard Error 0.77
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Counting Recall
|
-2.26 units on a scale
Standard Error 1.36
|
-1.61 units on a scale
Standard Error 1.21
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Backward Digit Recall
|
-0.31 units on a scale
Standard Error 0.82
|
1.76 units on a scale
Standard Error 0.74
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=10 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Backward Digit Recall
|
1.82 units on a scale
Standard Error 1.23
|
2.15 units on a scale
Standard Error 1.32
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Digit Recall
|
2.70 units on a scale
Standard Error 1.76
|
0.94 units on a scale
Standard Error 1.93
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Word List Matching
|
-0.79 units on a scale
Standard Error 1.61
|
2.03 units on a scale
Standard Error 1.84
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Word List Recall
|
1.50 units on a scale
Standard Error 1.06
|
1.17 units on a scale
Standard Error 1.18
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
NonWord
|
1.41 units on a scale
Standard Error 0.82
|
-0.13 units on a scale
Standard Error 0.90
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Block Recall
|
1.03 units on a scale
Standard Error 1.36
|
0.44 units on a scale
Standard Error 1.67
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Mazes Memory Score
|
2.70 units on a scale
Standard Error 1.61
|
0.16 units on a scale
Standard Error 1.73
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Listening Recall
|
1.53 units on a scale
Standard Error 1.06
|
1.57 units on a scale
Standard Error 1.18
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Counting Recall
|
0.31 units on a scale
Standard Error 1.02
|
-1.02 units on a scale
Standard Error 1.14
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=14 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=13 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
|
-7.22 units on a scale
Standard Error 4.756
|
-2.82 units on a scale
Standard Error 5.022
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=13 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=12 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
|
-1.88 units on a scale
Standard Error 1.441
|
-2.51 units on a scale
Standard Error 1.492
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Spelling
|
-1.81 units on a scale
Standard Error 2.87
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Spelling of Sounds
|
4.67 units on a scale
Standard Error 4.82
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Basic Reading Skills
|
3.41 units on a scale
Standard Error 1.72
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Passage Comprehension Score
|
2.17 units on a scale
Standard Error 5.68
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Reading Fluency
|
8.96 units on a scale
Standard Error 3.63
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Reading Comprehension
|
0.24 units on a scale
Standard Error 1.56
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Letter Word Identification
|
2.12 units on a scale
Standard Error 1.67
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Word Attack Score
|
5.37 units on a scale
Standard Error 4.71
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Reading Vocabulary Score
|
-2.28 units on a scale
Standard Error 2.18
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Letter Word Identification
|
2.40 units on a scale
Standard Error 3.30
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Word Attack Score
|
-0.78 units on a scale
Standard Error 0.21
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Reading Vocabulary
|
0.71 units on a scale
Standard Error 1.16
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Reading Fluency
|
2.24 units on a scale
Standard Error 0.27
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Reading Comprehension
|
2.61 units on a scale
Standard Error 1.31
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Spelling
|
1.29 units on a scale
Standard Error 3.68
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Spelling of Sounds
|
-1.79 units on a scale
Standard Error 1.03
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Basic Reading Skills
|
0.70 units on a scale
Standard Error 0.04
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Passage Comprehension Score
|
3.58 units on a scale
Standard Error 2.01
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Letter Word Identification
|
-1.89 units on a scale
Standard Error 0.39
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Word Attack Score
|
-1.87 units on a scale
Standard Error 1.73
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Reading Vocabulary
|
5.88 units on a scale
Standard Error 3.40
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Reading Fluency
|
2.93 units on a scale
Standard Error 3.82
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Reading Comprehension
|
4.77 units on a scale
Standard Error 2.39
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Spelling
|
4.04 units on a scale
Standard Error 2.79
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Spelling of Sounds
|
6.80 units on a scale
Standard Error 2.79
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Basic Reading Skills
|
-2.44 units on a scale
Standard Error 0.77
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Passage Comprehension Score
|
-3.16 units on a scale
Standard Error 1.09
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Phonological Awareness
|
-0.41 units on a scale
Standard Error 0.67
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Phonological Memory
|
-4.63 units on a scale
Standard Error 2.41
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Rapid Naming Score
|
3.99 units on a scale
Standard Error 4.49
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Phonological Awareness
|
12.69 units on a scale
Standard Error 1.89
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Phonological Memory
|
3.40 units on a scale
Standard Error 2.27
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Rapid Naming Score
|
4.72 units on a scale
Standard Error 3.47
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Phonological Awareness
|
5.90 units on a scale
Standard Error 6.17
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Phonological Memory
|
5.61 units on a scale
Standard Error 2.30
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Rapid Naming Score
|
2.67 units on a scale
Standard Error 0.32
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Oral Reading Rate
|
0.63 units on a scale
Standard Error 0.79
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Accuracy
|
-1.93 units on a scale
Standard Error 0.47
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Fluency
|
-0.66 units on a scale
Standard Error 0.45
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Reading Comprehension
|
-0.23 units on a scale
Standard Error 2.86
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Oral Reading Quotient
|
-9.53 units on a scale
Standard Error 14.45
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Oral Reading Rate
|
0.22 units on a scale
Standard Error 0.25
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Accuracy
|
0.17 units on a scale
Standard Error 0.02
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Fluency
|
-0.28 units on a scale
Standard Error 0.34
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Reading Comprehension
|
-0.61 units on a scale
Standard Error 0.31
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Oral Reading Quotient
|
-2.23 units on a scale
Standard Error 1.89
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Oral Reading Rate
|
0.05 units on a scale
Standard Error 0.63
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Accuracy
|
-1.44 units on a scale
Standard Error 0.45
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Fluency
|
-0.20 units on a scale
Standard Error 0.22
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Reading Comprehension
|
-0.02 units on a scale
Standard Error 1.07
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Oral Reading Quotient
|
-1.37 units on a scale
Standard Error 4.86
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=15 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone
|
3.20 units on a scale
Standard Error 3.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=10 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia
ADHD + Dyslexia
|
2.77 units on a scale
Standard Error 1.99
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia
ADHD Alone
|
6.75 units on a scale
Standard Error 0.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WMTB-C measurements. No participants by design were on placebo for both study periods II and III.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Word List Recall Score
|
0.75 units on a scale
Standard Error 1.65
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Digit Recall Score
|
0.47 units on a scale
Standard Error 1.00
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Word List Matching Score
|
1.29 units on a scale
Standard Error 2.62
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Nonword List Recall Score
|
-0.96 units on a scale
Standard Error 2.45
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Block Recall Score
|
1.25 units on a scale
Standard Error 2.51
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Mazes Memory Score
|
1.91 units on a scale
Standard Error 3.74
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Listening Recall Score
|
4.15 units on a scale
Standard Error 2.14
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Counting Recall Score
|
-0.88 units on a scale
Standard Error 1.39
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Backwards Digit Recall Score
|
-0.64 units on a scale
Standard Error 2.95
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Word List Matching Score
|
-4.12 units on a scale
Standard Error 1.25
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Block Recall Score
|
0.56 units on a scale
Standard Error 1.13
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Mazes Memory Score
|
-0.22 units on a scale
Standard Error 2.73
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Digit Recall Score
|
0.06 units on a scale
Standard Error 0.07
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Word List Recall Score
|
3.05 units on a scale
Standard Error 1.51
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Nonword List Recall Score
|
1.78 units on a scale
Standard Error 0.42
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Listening Recall Score
|
0.73 units on a scale
Standard Error 3.37
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Counting Recall Score
|
-0.55 units on a scale
Standard Error 2.47
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Backward Digit Recall Score
|
0.05 units on a scale
Standard Error 2.95
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Word List Recall Score
|
1.25 units on a scale
Standard Error 0.49
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Digit Recall Score
|
3.75 units on a scale
Standard Error 0.93
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Word List Matching Score
|
-3.37 units on a scale
Standard Error 0.37
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Nonword List Recall Score
|
1.12 units on a scale
Standard Error 0.60
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Block Recall Score
|
3.65 units on a scale
Standard Error 3.48
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Mazes Memory Score
|
-1.09 units on a scale
Standard Error 1.43
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Listening Recall Score
|
4.24 units on a scale
Standard Error 1.96
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Counting Recall Score
|
-3.05 units on a scale
Standard Error 1.67
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Backward Digit Recall Score
|
-0.45 units on a scale
Standard Error 0.00
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
|
-10.07 units on a scale
Standard Error 6.70
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Outcome measures
| Measure |
Atomoxetine
n=11 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD + Dyslexia
|
-9.44 units on a scale
Standard Error 7.43
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD Alone
|
-9.33 units on a scale
Standard Error 5.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone
|
12.60 units on a scale
Standard Error 8.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Outcome measures
| Measure |
Atomoxetine
n=11 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia
ADHD + Dyslexia
|
-12.96 units on a scale
Standard Error 2.44
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia
ADHD Alone
|
-18.76 units on a scale
Standard Error 5.89
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: For this outcome measure, there were no data collected beyond 16 weeks.
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 16, Up to 32 WeeksPopulation: Stroop Tasks data were not collected.
Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: For this outcome measure, there were no data collected beyond 16 weeks.
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: Stroop Tasks data were not collected.
Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 16, Up to 32 WeeksPopulation: All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Letter Word Identification
|
2.92 units on a scale
Standard Error 2.45
|
-4.08 units on a scale
Standard Error 2.02
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Basic Reading Skills
|
2.87 units on a scale
Standard Error 1.44
|
-3.80 units on a scale
Standard Error 1.19
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Word Attack Score
|
2.79 units on a scale
Standard Error 2.68
|
-1.01 units on a scale
Standard Error 2.10
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Reading Fluency
|
11.03 units on a scale
Standard Error 3.14
|
-1.53 units on a scale
Standard Error 2.61
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Reading Comprehension
|
4.52 units on a scale
Standard Error 2.60
|
-6.86 units on a scale
Standard Error 2.16
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Spelling
|
-2.90 units on a scale
Standard Error 3.73
|
-1.72 units on a scale
Standard Error 3.00
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Spelling of Sounds
|
3.33 units on a scale
Standard Error 3.11
|
0.30 units on a scale
Standard Error 2.59
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Passage Comprehension Score
|
4.51 units on a scale
Standard Error 3.30
|
-6.92 units on a scale
Standard Error 2.74
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Reading Vocabulary Score
|
3.02 units on a scale
Standard Error 2.04
|
-4.84 units on a scale
Standard Error 1.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Reading Fluency
|
5.46 units on a scale
Standard Error 2.77
|
6.21 units on a scale
Standard Error 2.84
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Spelling of Sounds
|
-10.17 units on a scale
Standard Error 3.40
|
-3.52 units on a scale
Standard Error 3.23
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Word Attack Score
|
-2.65 units on a scale
Standard Error 1.81
|
-2.62 units on a scale
Standard Error 1.63
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Letter Word Identification
|
0.50 units on a scale
Standard Error 3.19
|
-1.07 units on a scale
Standard Error 3.00
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Reading Vocabulary Score
|
0.64 units on a scale
Standard Error 2.17
|
-4.08 units on a scale
Standard Error 2.08
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Reading Comprehension
|
0.86 units on a scale
Standard Error 2.25
|
-2.49 units on a scale
Standard Error 2.07
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Spelling
|
0.45 units on a scale
Standard Error 2.46
|
0.86 units on a scale
Standard Error 2.32
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Basic Reading Skills
|
-1.29 units on a scale
Standard Error 1.06
|
-2.17 units on a scale
Standard Error 1.00
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Passage Comprehension Score
|
0.15 units on a scale
Standard Error 2.06
|
0.52 units on a scale
Standard Error 1.85
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Spelling
|
2.07 units on a scale
Standard Error 4.66
|
1.15 units on a scale
Standard Error 3.81
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Spelling of Sounds
|
-2.65 units on a scale
Standard Error 3.02
|
2.65 units on a scale
Standard Error 2.90
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Word Attack Score
|
-1.56 units on a scale
Standard Error 2.06
|
-0.58 units on a scale
Standard Error 1.85
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Letter Word Identification
|
-3.89 units on a scale
Standard Error 4.46
|
-1.61 units on a scale
Standard Error 4.01
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Reading Vocabulary Score
|
5.15 units on a scale
Standard Error 5.51
|
-3.62 units on a scale
Standard Error 4.26
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Reading Fluency
|
13.05 units on a scale
Standard Error 2.32
|
4.88 units on a scale
Standard Error 1.11
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Reading Comprehension
|
3.86 units on a scale
Standard Error 2.94
|
3.26 units on a scale
Standard Error 2.67
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Basic Reading Skills
|
-2.70 units on a scale
Standard Error 3.56
|
-1.97 units on a scale
Standard Error 3.17
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Passage Comprehension Score
|
6.86 units on a scale
Standard Error 3.42
|
2.31 units on a scale
Standard Error 3.00
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Phonological Awareness
|
-1.19 units on a scale
Standard Error 4.03
|
2.06 units on a scale
Standard Error 2.82
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Phonological Memory
|
-6.96 units on a scale
Standard Error 3.71
|
-1.76 units on a scale
Standard Error 3.23
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Rapid Naming Score
|
7.24 units on a scale
Standard Error 5.91
|
-2.42 units on a scale
Standard Error 4.82
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Phonological Awareness
|
3.54 units on a scale
Standard Error 1.51
|
5.29 units on a scale
Standard Error 1.42
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Phonological Memory
|
-2.65 units on a scale
Standard Error 3.34
|
0.12 units on a scale
Standard Error 2.88
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Rapid Naming Score
|
2.65 units on a scale
Standard Error 2.02
|
1.21 units on a scale
Standard Error 1.64
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=5 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Phonological Awareness
|
-0.33 units on a scale
Standard Error 2.89
|
9.67 units on a scale
Standard Error 2.61
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Phonological Memory
|
3.59 units on a scale
Standard Error 3.37
|
0.84 units on a scale
Standard Error 3.58
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Rapid Naming Score
|
1.53 units on a scale
Standard Error 2.36
|
3.51 units on a scale
Standard Error 2.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone
|
-0.17 units on a scale
Standard Error 1.808
|
4.17 units on a scale
Standard Error 1.808
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=10 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=11 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD Alone
|
2.03 units on a scale
Standard Error 4.179
|
1.37 units on a scale
Standard Error 4.179
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD + Dyslexia
|
3.74 units on a scale
Standard Error 1.261
|
1.38 units on a scale
Standard Error 1.151
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Oral Reading Quotient
|
-3.04 units on a scale
Standard Error 10.51
|
-4.91 units on a scale
Standard Error 8.62
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Oral Reading Rate
|
0.27 units on a scale
Standard Error 0.43
|
-0.64 units on a scale
Standard Error 0.36
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Accuracy
|
0.40 units on a scale
Standard Error 0.62
|
-0.69 units on a scale
Standard Error 0.48
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Fluency
|
0.52 units on a scale
Standard Error 0.67
|
-0.64 units on a scale
Standard Error 0.49
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Reading Comprehension
|
0.06 units on a scale
Standard Error 1.40
|
-0.76 units on a scale
Standard Error 1.20
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
Fluency
|
0.33 units on a scale
Standard Error 1.15
|
0.52 units on a scale
Standard Error 1.08
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
Reading Comprehension
|
1.75 units on a scale
Standard Error 1.42
|
3.64 units on a scale
Standard Error 1.29
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
Oral Reading Rate
|
0.37 units on a scale
Standard Error 0.73
|
0.31 units on a scale
Standard Error 0.66
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
Accuracy
|
0.07 units on a scale
Standard Error 0.84
|
0.45 units on a scale
Standard Error 0.68
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
Oral Reading Quotient
|
7.16 units on a scale
Standard Error 4.57
|
12.92 units on a scale
Standard Error 4.32
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Oral Reading Rate
|
0.36 units on a scale
Standard Error 0.99
|
-0.35 units on a scale
Standard Error 0.70
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Accuracy
|
-1.29 units on a scale
Standard Error 1.00
|
0.15 units on a scale
Standard Error 0.82
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Fluency
|
-0.54 units on a scale
Standard Error 0.76
|
-0.38 units on a scale
Standard Error 0.57
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Reading Comprehension
|
3.46 units on a scale
Standard Error 1.05
|
-0.04 units on a scale
Standard Error 0.75
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Oral Reading Quotient
|
8.27 units on a scale
Standard Error 8.94
|
-3.13 units on a scale
Standard Error 5.38
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Digit Recall Score
|
-1.77 units on a scale
Standard Error 1.78
|
0.45 units on a scale
Standard Error 1.48
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Word List Matching Score
|
3.98 units on a scale
Standard Error 4.14
|
1.84 units on a scale
Standard Error 2.99
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Word List Recall Score
|
-0.68 units on a scale
Standard Error 2.56
|
-1.90 units on a scale
Standard Error 2.27
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Nonword List Recall Score
|
2.25 units on a scale
Standard Error 0.71
|
-0.40 units on a scale
Standard Error 0.55
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Block Recall Score
|
1.57 units on a scale
Standard Error 1.55
|
-1.73 units on a scale
Standard Error 1.07
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Mazes Memory Score
|
6.90 units on a scale
Standard Error 3.29
|
1.27 units on a scale
Standard Error 2.76
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Listening Recall Score
|
3.44 units on a scale
Standard Error 1.11
|
-1.23 units on a scale
Standard Error 0.95
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Counting Recall Score
|
-2.05 units on a scale
Standard Error 2.23
|
-2.21 units on a scale
Standard Error 1.87
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Backward Digit Recall Score
|
2.74 units on a scale
Standard Error 4.47
|
2.49 units on a scale
Standard Error 2.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Digit Recall Score
|
-1.25 units on a scale
Standard Error 0.63
|
1.83 units on a scale
Standard Error 0.59
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Word List Matching Score
|
-4.48 units on a scale
Standard Error 1.74
|
-4.40 units on a scale
Standard Error 1.60
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Word List Recall Score
|
2.34 units on a scale
Standard Error 0.66
|
2.28 units on a scale
Standard Error 0.61
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
NonWord List Recall
|
2.17 units on a scale
Standard Error 1.00
|
0.64 units on a scale
Standard Error 1.57
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Block Recall Score
|
-1.71 units on a scale
Standard Error 2.57
|
3.81 units on a scale
Standard Error 1.89
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Mazes Memory Score
|
-2.82 units on a scale
Standard Error 2.69
|
1.28 units on a scale
Standard Error 2.55
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Listening Recall Score
|
1.93 units on a scale
Standard Error 1.80
|
0.49 units on a scale
Standard Error 1.45
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Counting Recall Score
|
1.34 units on a scale
Standard Error 2.52
|
-0.89 units on a scale
Standard Error 2.46
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Backward Recall Score
|
0.76 units on a scale
Standard Error 2.03
|
-0.14 units on a scale
Standard Error 1.94
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline.
Outcome measures
| Measure |
Atomoxetine
n=5 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=5 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Block Recall Score
|
-1.14 units on a scale
Standard Error 1.96
|
0.59 units on a scale
Standard Error 1.72
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Mazes Memory Score
|
1.11 units on a scale
Standard Error 2.35
|
-2.51 units on a scale
Standard Error 2.00
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Listening Recall Score
|
-1.12 units on a scale
Standard Error 3.23
|
-0.09 units on a scale
Standard Error 2.94
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Counting Recall Score
|
-0.03 units on a scale
Standard Error 4.53
|
-2.90 units on a scale
Standard Error 3.75
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Backward Recall Score
|
-0.68 units on a scale
Standard Error 2.03
|
-0.46 units on a scale
Standard Error 1.83
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Digit Recall Score
|
2.56 units on a scale
Standard Error 2.92
|
-0.97 units on a scale
Standard Error 2.19
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Word List Matching Score
|
-1.22 units on a scale
Standard Error 3.84
|
-1.71 units on a scale
Standard Error 3.48
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Word List Recall Score
|
-1.23 units on a scale
Standard Error 1.41
|
1.71 units on a scale
Standard Error 1.22
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
NonWord List Recall
|
-1.29 units on a scale
Standard Error 1.02
|
-1.12 units on a scale
Standard Error 0.87
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
|
-6.96 units on a scale
Standard Error 5.240
|
7.13 units on a scale
Standard Error 5.240
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=10 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=11 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD + Dyslexia
|
-0.90 units on a scale
Standard Error 8.646
|
14.59 units on a scale
Standard Error 7.892
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD Alone
|
1.01 units on a scale
Standard Error 4.416
|
3.69 units on a scale
Standard Error 4.461
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=6 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=18 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
|
3.02 units on a scale
Standard Error 2.537
|
0.27 units on a scale
Standard Error 1.457
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16, Up to Week 32Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=10 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=32 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD + Dyslexia
|
-0.32 units on a scale
Standard Error 3.991
|
-6.38 units on a scale
Standard Error 1.946
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia
ADHD alone
|
-6.29 units on a scale
Standard Error 2.546
|
-8.83 units on a scale
Standard Error 1.561
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants who received at least one dose of study drug.
The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Atomoxetine
n=16 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=15 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia
|
13 Participants
|
11 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All randomized participants who received at least one dose of study drug.
The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Atomoxetine
n=28 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=29 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
ADHD + Dyslexia
|
12 Participants
|
14 Participants
|
—
|
—
|
—
|
|
The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
ADHD alone
|
12 Participants
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 16 Weeks Up to Week 32Population: All randomized participants who received at least one dose of study drug.
The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Atomoxetine
n=7 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=6 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
n=12 Participants
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
The Number of Participants With TEAE in Participants With Dyslexia
|
3 Participants
|
2 Participants
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 16 Up to Week 32Population: All randomized participants who received at least one dose of study drug.
The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Atomoxetine
n=12 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=12 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
n=18 Participants
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
ADHD + Dyslexia
|
2 Participants
|
2 Participants
|
10 Participants
|
—
|
—
|
|
The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
ADHD Alone
|
3 Participants
|
4 Participants
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 32 WeeksPopulation: All randomized participants who received at least one dose of study drug.
Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Atomoxetine
n=45 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
n=44 Participants
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
n=18 Participants
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
n=18 Participants
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
n=35 Participants
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
35 Participants
|
31 Participants
|
8 Participants
|
8 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline WJ III measurements.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Letter Word Identification
|
-3.42 units on a scale
Standard Deviation 5.18
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Word Attack Score
|
-2.74 units on a scale
Standard Deviation 6.54
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Reading Vocabulary
|
-0.63 units on a scale
Standard Deviation 7.87
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Reading Fluency
|
5.37 units on a scale
Standard Deviation 10.45
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Reading Comprehension
|
-1.84 units on a scale
Standard Deviation 6.98
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Spelling
|
2.21 units on a scale
Standard Deviation 5.70
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Spelling of Sounds
|
-2.16 units on a scale
Standard Deviation 18.35
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Basic Reading Skills
|
-3.58 units on a scale
Standard Deviation 5.10
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Passage Comprehension
|
-2.11 units on a scale
Standard Deviation 7.89
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline CTOPP measurements.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Phonological Awareness
|
3.63 units on a scale
Standard Deviation 11.12
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Phonological Memory
|
2.05 units on a scale
Standard Deviation 3.88
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Rapid Naming Score
|
0.63 units on a scale
Standard Deviation 10.75
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Oral Reading Rate
|
0.74 units on a scale
Standard Deviation 1.52
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Accuracy
|
0.68 units on a scale
Standard Deviation 2.60
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Fluency
|
0.74 units on a scale
Standard Deviation 1.97
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Reading Comprehension
|
-0.16 units on a scale
Standard Deviation 2.95
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Oral Reading Quotient
|
-3.42 units on a scale
Standard Deviation 24.58
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline TOWRE measurements.
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants
|
0.20 units on a scale
Standard Error 1.487
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Digit Recall Score
|
2.47 units on a scale
Standard Deviation 4.50
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Word List Matching Score
|
-0.95 units on a scale
Standard Deviation 5.38
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Word List Recall Score
|
1.79 units on a scale
Standard Deviation 2.53
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Nonword List Recall Score
|
0.58 units on a scale
Standard Deviation 4.31
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Block Recall Score
|
1.63 units on a scale
Standard Deviation 4.83
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Mazes Memory Score
|
1.11 units on a scale
Standard Deviation 7.72
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Listening Recall Score
|
-0.58 units on a scale
Standard Deviation 3.61
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Counting Recall Score
|
0.37 units on a scale
Standard Deviation 3.44
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Backward Digit Recall Score
|
2.95 units on a scale
Standard Deviation 4.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All participants who had evaluable baseline and post baseline BADD-A measurements.
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
|
1.42 units on a scale
Standard Error 3.572
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants
|
0.15 units on a scale
Standard Error 1.055
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All healthy participants who had baseline and post-baseline WJ III measurements.
WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Letter Word Identification
|
-0.37 units on a scale
Standard Deviation 5.45
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Word Attack Score
|
-3.58 units on a scale
Standard Deviation 7.23
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Reading Vocabulary
|
0.79 units on a scale
Standard Deviation 7.79
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Reading Fluency
|
7.84 units on a scale
Standard Deviation 11.69
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Spelling
|
1.95 units on a scale
Standard Deviation 4.49
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Spelling of Sounds
|
3.63 units on a scale
Standard Deviation 18.94
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Basic Reading Skills Score
|
-2.00 units on a scale
Standard Deviation 5.35
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Passage Comprehension
|
0.05 units on a scale
Standard Deviation 9.34
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Reading Comprehension
|
0.47 units on a scale
Standard Deviation 7.99
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 weeksPopulation: All healthy participants who had evaluable baseline and post baseline CTOPP measurements.
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Phonological Memory
|
2.05 units on a scale
Standard Deviation 3.88
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Rapid Naming Score
|
0.63 units on a scale
Standard Deviation 10.75
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Phonological Awareness
|
3.63 units on a scale
Standard Deviation 11.12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Oral Reading Rate
|
0.74 units on a scale
Standard Deviation 1.52
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Accuracy
|
0.68 units on a scale
Standard Deviation 2.60
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Fluency
|
0.74 units on a scale
Standard Deviation 1.97
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Oral Reading Quotient
|
-3.42 units on a scale
Standard Deviation 24.58
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Comprehension
|
-0.16 units on a scale
Standard Deviation 2.95
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline TOWRE measurements.
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants
|
4.05 units on a scale
Standard Error 1.578
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Digit Recall Score
|
2.47 units on a scale
Standard Deviation 4.50
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Word List Matching Score
|
-0.95 units on a scale
Standard Deviation 5.38
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Word List Recall Score
|
1.79 units on a scale
Standard Deviation 2.53
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Nonword List Recall Score
|
0.58 units on a scale
Standard Deviation 4.31
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Block Recall Score
|
1.63 units on a scale
Standard Deviation 4.83
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Mazes Memory Score
|
1.11 units on a scale
Standard Deviation 7.72
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Listening Recall Score
|
-0.58 units on a scale
Standard Deviation 3.61
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Counting Recall Score
|
0.37 units on a scale
Standard Deviation 3.44
|
—
|
—
|
—
|
—
|
|
Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Backwards Digit Recall Score
|
2.95 units on a scale
Standard Deviation 4.17
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline BADD-A measurements.
The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
|
5.74 units on a scale
Standard Error 3.991
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 32 WeeksPopulation: All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.
Outcome measures
| Measure |
Atomoxetine
n=19 Participants
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
|
Placebo
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
|
PLA/ATX
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants
|
1.17 units on a scale
Standard Error 1.046
|
—
|
—
|
—
|
—
|
Adverse Events
Atomoxetine
Placebo
ATX/ATX
ATX/PLA
PLA/ATX
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=45 participants at risk
Atomoxetine 1.0 to 1.4 mg/kg was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
|
Placebo
n=44 participants at risk
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
|
ATX/ATX
n=18 participants at risk
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
ATX/PLA
n=18 participants at risk
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
PLA/ATX
n=35 participants at risk
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
9.1%
4/44 • Number of events 4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.7%
2/35 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
22.2%
10/45 • Number of events 10 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
27.3%
12/44 • Number of events 12 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
11.4%
4/35 • Number of events 4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.3%
1/44 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Gastrointestinal disorders
Nausea
|
15.6%
7/45 • Number of events 7 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
11.4%
5/44 • Number of events 5 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.9%
1/35 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.7%
2/35 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
General disorders
Fatigue
|
33.3%
15/45 • Number of events 15 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
11.4%
5/44 • Number of events 5 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
8.6%
3/35 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
General disorders
Therapeutic response unexpected
|
28.9%
13/45 • Number of events 20 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
22.7%
10/44 • Number of events 12 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
11.1%
2/18 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
16.7%
3/18 • Number of events 5 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
14.3%
5/35 • Number of events 6 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Infections and infestations
Influenza
|
6.7%
3/45 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
4.5%
2/44 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Infections and infestations
Rhinitis
|
8.9%
4/45 • Number of events 4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
9.1%
4/44 • Number of events 4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.9%
1/35 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/45 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
4.5%
2/44 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.7%
2/35 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/45 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
6.8%
3/44 • Number of events 4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Investigations
Weight decreased
|
17.8%
8/45 • Number of events 8 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
4.5%
2/44 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
25.7%
9/35 • Number of events 9 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.8%
8/45 • Number of events 8 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
4.5%
2/44 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
22.9%
8/35 • Number of events 8 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.2%
1/45 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
6.8%
3/44 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.9%
1/35 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Nervous system disorders
Dizziness
|
8.9%
4/45 • Number of events 4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.9%
1/35 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Nervous system disorders
Headache
|
26.7%
12/45 • Number of events 12 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
13.6%
6/44 • Number of events 6 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
8.6%
3/35 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
4.5%
2/44 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.7%
2/35 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Psychiatric disorders
Emotional disorder
|
6.7%
3/45 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.3%
1/44 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
11.4%
4/35 • Number of events 4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.3%
1/44 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.7%
2/35 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Psychiatric disorders
Irritability
|
6.7%
3/45 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.3%
1/44 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
14.3%
5/35 • Number of events 5 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Psychiatric disorders
Mood swings
|
2.2%
1/45 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
6.8%
3/44 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/17 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/10 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
3/45 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
9.1%
4/44 • Number of events 4 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
3/45 • Number of events 3 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
4.5%
2/44 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
11.1%
2/18 • Number of events 2 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.9%
1/35 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/45 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/44 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
|
Social circumstances
Educational problem
|
2.2%
1/45 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
2.3%
1/44 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/18 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
5.6%
1/18 • Number of events 1 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
0.00%
0/35 • Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60