Trial Outcomes & Findings for Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study) (NCT NCT00997984)
NCT ID: NCT00997984
Last Updated: 2021-06-08
Results Overview
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
340 participants
Primary outcome timeframe
Baseline and up to 8 weeks
Results posted on
2021-06-08
Participant Flow
Participant milestones
| Measure |
Placebo
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
|---|---|---|---|
|
Overall Study
STARTED
|
113
|
113
|
114
|
|
Overall Study
COMPLETED
|
76
|
79
|
88
|
|
Overall Study
NOT COMPLETED
|
37
|
34
|
26
|
Reasons for withdrawal
| Measure |
Placebo
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
8
|
8
|
|
Overall Study
Protocol Violation
|
1
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
5
|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
20
|
6
|
3
|
|
Overall Study
Met exclusion criteria
|
1
|
0
|
0
|
|
Overall Study
non-compliance
|
0
|
2
|
3
|
|
Overall Study
Wrong medication dispensed
|
0
|
1
|
0
|
|
Overall Study
Suicidal ideation
|
0
|
0
|
1
|
|
Overall Study
Work schedule
|
0
|
0
|
2
|
Baseline Characteristics
Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
Baseline characteristics by cohort
| Measure |
Placebo
n=112 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=107 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=114 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
8.9 years
STANDARD_DEVIATION 1.78 • n=5 Participants
|
9.1 years
STANDARD_DEVIATION 1.77 • n=7 Participants
|
9.3 years
STANDARD_DEVIATION 1.76 • n=5 Participants
|
9.1 years
STANDARD_DEVIATION 1.77 • n=4 Participants
|
|
Age, Customized
6-12 years
|
112 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
333 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
110 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Full Analysis Set (FAS) defined as all subjects who had taken at least 1 dose of investigational product during the study.
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=111 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=215 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)
|
-10.6 Units on a scale
Standard Error 1.20
|
-20.0 Units on a scale
Standard Error 1.23
|
-20.4 Units on a scale
Standard Error 1.19
|
-20.2 Units on a scale
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: FAS
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=112 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=216 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Mildly ill
|
15.5 Percent of Participants
|
32.7 Percent of Participants
|
27.7 Percent of Participants
|
30.1 Percent of Participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Moderately ill
|
34.5 Percent of Participants
|
22.1 Percent of Participants
|
22.3 Percent of Participants
|
22.2 Percent of Participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Markedly ill
|
30.0 Percent of Participants
|
11.5 Percent of Participants
|
10.7 Percent of Participants
|
11.1 Percent of Participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Normal, not at all ill
|
4.5 Percent of Participants
|
11.5 Percent of Participants
|
16.1 Percent of Participants
|
13.9 Percent of Participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Borderline mentally ill
|
8.2 Percent of Participants
|
20.2 Percent of Participants
|
20.5 Percent of Participants
|
20.4 Percent of Participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Severely ill
|
7.3 Percent of Participants
|
1.0 Percent of Participants
|
2.7 Percent of Participants
|
1.9 Percent of Participants
|
|
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF
Among the most extremely ill
|
0.0 Percent of Participants
|
1.0 Percent of Participants
|
0.0 Percent of Participants
|
0.5 Percent of Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: FAS
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=112 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=216 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF
|
31.8 Percent of Participants
|
66.3 Percent of Participants
|
67.0 Percent of Participants
|
66.7 Percent of Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=111 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=215 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF
|
-3.1 Units on a scale
Standard Error 0.53
|
-2.7 Units on a scale
Standard Error 0.55
|
-1.4 Units on a scale
Standard Error 0.53
|
-2.0 Units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: FAS
HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
Outcome measures
| Measure |
Placebo
n=99 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=97 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=100 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=197 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF
|
0.043 Units on a scale
Standard Deviation 0.1159
|
0.056 Units on a scale
Standard Deviation 0.1166
|
0.063 Units on a scale
Standard Deviation 0.1100
|
0.060 Units on a scale
Standard Deviation 0.1131
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: FAS
The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Outcome measures
| Measure |
Placebo
n=86 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=87 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=91 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=178 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF
|
-10.4 Units on a scale
Standard Error 1.89
|
-22.9 Units on a scale
Standard Error 1.88
|
-21.2 Units on a scale
Standard Error 1.84
|
-22.0 Units on a scale
Standard Error 1.31
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: FAS
The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior.
Outcome measures
| Measure |
Placebo
n=109 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=103 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=111 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=214 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF
|
-0.7 Units on a scale
Standard Error 0.18
|
-0.5 Units on a scale
Standard Error 0.18
|
-1.0 Units on a scale
Standard Error 0.18
|
-0.8 Units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: FAS
Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=112 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=216 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Very poor
|
2.7 Percent of Participants
|
1.0 Percent of Participants
|
0.0 Percent of Participants
|
0.5 Percent of Participants
|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Poor
|
6.4 Percent of Participants
|
5.8 Percent of Participants
|
7.1 Percent of Participants
|
6.5 Percent of Participants
|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Average
|
29.1 Percent of Participants
|
26.0 Percent of Participants
|
27.7 Percent of Participants
|
26.9 Percent of Participants
|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Good
|
35.5 Percent of Participants
|
42.3 Percent of Participants
|
50.9 Percent of Participants
|
46.8 Percent of Participants
|
|
Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF
Very good
|
26.4 Percent of Participants
|
25.0 Percent of Participants
|
14.3 Percent of Participants
|
19.4 Percent of Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: FAS
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3.
Outcome measures
| Measure |
Placebo
n=95 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=97 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=98 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=195 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF
|
-0.20 Units on a scale
Standard Error 0.038
|
-0.35 Units on a scale
Standard Error 0.037
|
-0.37 Units on a scale
Standard Error 0.037
|
-0.36 Units on a scale
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Population
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=112 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=216 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Supine
|
-0.5 mmHg
Standard Deviation 9.39
|
-1.6 mmHg
Standard Deviation 9.86
|
-2.1 mmHg
Standard Deviation 10.26
|
-1.9 mmHg
Standard Deviation 10.05
|
|
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Standing
|
-1.4 mmHg
Standard Deviation 9.08
|
-3.3 mmHg
Standard Deviation 11.23
|
-2.7 mmHg
Standard Deviation 11.23
|
-3.0 mmHg
Standard Deviation 11.20
|
|
Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF
Orthostatic
|
-0.9 mmHg
Standard Deviation 9.14
|
-1.7 mmHg
Standard Deviation 9.89
|
-0.6 mmHg
Standard Deviation 8.93
|
-1.1 mmHg
Standard Deviation 9.40
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Population
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=112 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=216 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
Supine
|
-0.3 mmHg
Standard Deviation 7.10
|
-0.8 mmHg
Standard Deviation 7.98
|
-2.1 mmHg
Standard Deviation 8.71
|
-1.5 mmHg
Standard Deviation 8.37
|
|
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
Standing
|
0.2 mmHg
Standard Deviation 7.74
|
-2.2 mmHg
Standard Deviation 8.04
|
-2.5 mmHg
Standard Deviation 9.91
|
-2.4 mmHg
Standard Deviation 9.04
|
|
Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF
Orthostatic
|
0.4 mmHg
Standard Deviation 6.31
|
-1.4 mmHg
Standard Deviation 9.35
|
-0.4 mmHg
Standard Deviation 8.94
|
-0.9 mmHg
Standard Deviation 9.13
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Population
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=112 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=216 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Pulse Rate at Week 8 - LOCF
Supine
|
1.0 beats per minute
Standard Deviation 11.93
|
-3.7 beats per minute
Standard Deviation 12.35
|
-3.8 beats per minute
Standard Deviation 11.95
|
-3.8 beats per minute
Standard Deviation 12.12
|
|
Change From Baseline in Pulse Rate at Week 8 - LOCF
Standing
|
0.9 beats per minute
Standard Deviation 12.02
|
-1.9 beats per minute
Standard Deviation 14.84
|
-2.3 beats per minute
Standard Deviation 11.41
|
-2.1 beats per minute
Standard Deviation 13.15
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Population
Outcome measures
| Measure |
Placebo
n=110 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=104 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=112 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=216 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Oral Temperature at Week 8 - LOCF
|
0.06 º F
Standard Deviation 0.779
|
-0.12 º F
Standard Deviation 0.659
|
-0.09 º F
Standard Deviation 0.758
|
-0.10 º F
Standard Deviation 0.710
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Population
Outcome measures
| Measure |
Placebo
n=94 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=95 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=90 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=185 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Height at Week 8 - LOCF
|
0.28 inches
Standard Deviation 0.412
|
0.39 inches
Standard Deviation 0.602
|
0.43 inches
Standard Deviation 0.459
|
0.41 inches
Standard Deviation 0.536
|
SECONDARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Safety Population
Outcome measures
| Measure |
Placebo
n=94 Participants
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=95 Participants
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=92 Participants
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All-Active
n=187 Participants
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Change From Baseline in Weight at Week 8 - LOCF
|
2.15 pounds
Standard Deviation 2.774
|
2.37 pounds
Standard Deviation 2.684
|
2.64 pounds
Standard Deviation 3.006
|
2.50 pounds
Standard Deviation 2.843
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
SPD503 AM
Serious events: 1 serious events
Other events: 85 other events
Deaths: 0 deaths
SPD503 PM
Serious events: 2 serious events
Other events: 95 other events
Deaths: 0 deaths
All Active
Serious events: 3 serious events
Other events: 180 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=112 participants at risk
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=107 participants at risk
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=114 participants at risk
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All Active
n=221 participants at risk
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.93%
1/107 • Number of events 1
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.88%
1/114 • Number of events 1
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.90%
2/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Psychiatric disorders
Self-injurious ideation
|
0.00%
0/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.00%
0/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.88%
1/114 • Number of events 1
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.45%
1/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.00%
0/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.88%
1/114 • Number of events 1
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.45%
1/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
Other adverse events
| Measure |
Placebo
n=112 participants at risk
Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
|
SPD503 AM
n=107 participants at risk
SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
|
SPD503 PM
n=114 participants at risk
Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
|
All Active
n=221 participants at risk
The combined results of the SPD503 AM and PM groups
|
|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
12.5%
14/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
46.7%
50/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
42.1%
48/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
44.3%
98/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Nervous system disorders
Headache
|
10.7%
12/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
17.8%
19/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
15.8%
18/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
16.7%
37/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Nervous system disorders
Sedation
|
2.7%
3/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
14.0%
15/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
14.9%
17/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
14.5%
32/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Abdomonal pain upper
|
7.1%
8/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
6.5%
7/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
17.5%
20/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
12.2%
27/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
General disorders
Fatigue
|
2.7%
3/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
10.3%
11/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
11.4%
13/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
10.9%
24/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
General disorders
Irritability
|
2.7%
3/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
7.5%
8/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
7.0%
8/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
7.2%
16/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.89%
1/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.6%
6/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.3%
6/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.4%
12/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
11/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
7.5%
8/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
3.5%
4/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.4%
12/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
4/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
3.7%
4/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
6.1%
7/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.0%
11/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Nervous system disorders
Dizziness
|
2.7%
3/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.6%
6/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
4.4%
5/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.0%
11/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
6.5%
7/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
3.5%
4/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.0%
11/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Psychiatric disorders
Insomnia
|
3.6%
4/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.6%
6/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
2.6%
3/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
4.1%
9/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.7%
3/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.6%
6/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
2.6%
3/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
4.1%
9/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Renal and urinary disorders
Enuresis
|
0.89%
1/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.93%
1/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
5.3%
6/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
3.2%
7/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.4%
6/112
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.00%
0/107
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
1.8%
2/114
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
0.90%
2/221
Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER