Trial Outcomes & Findings for Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl (NCT NCT01081132)
NCT ID: NCT01081132
Last Updated: 2021-06-28
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
314 participants
Primary outcome timeframe
Baseline through week 13
Results posted on
2021-06-28
Participant Flow
Participant milestones
| Measure |
PLACEBO
Orally administered a once-daily dose
|
SPD503
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
157
|
|
Overall Study
COMPLETED
|
102
|
105
|
|
Overall Study
NOT COMPLETED
|
55
|
52
|
Reasons for withdrawal
| Measure |
PLACEBO
Orally administered a once-daily dose
|
SPD503
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
25
|
9
|
|
Overall Study
Withdrawal by Subject
|
13
|
16
|
|
Overall Study
Lost to Follow-up
|
4
|
11
|
|
Overall Study
Adverse Event
|
3
|
9
|
|
Overall Study
Non Compliance
|
4
|
2
|
|
Overall Study
Lack Of Compliance
|
0
|
1
|
|
Overall Study
Missed Visits
|
1
|
1
|
|
Overall Study
Stopped Taking Meds
|
2
|
0
|
|
Overall Study
Patient Did Not Complete Wk14 and 15
|
0
|
1
|
|
Overall Study
Declined Taper Phase
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
Baseline Characteristics
Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
Baseline characteristics by cohort
| Measure |
PLACEBO
n=155 Participants
Orally administered a once-daily dose
|
SPD503
n=157 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.6 Years
STANDARD_DEVIATION 1.44 • n=5 Participants
|
14.5 Years
STANDARD_DEVIATION 1.35 • n=7 Participants
|
14.5 Years
STANDARD_DEVIATION 1.39 • n=5 Participants
|
|
Age, Customized
<18 years
|
155 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
155 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through week 13Population: The Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. A mixed model repeated measures (MMRM) was used to analyze the observed change from the Baseline Visit scores at all post-baseline, pre-taper, on-treatment visits.
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=106 Participants
Orally administered a once-daily dose
|
SPD503
n=109 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13
|
-18.527 units on a scale
Standard Error 1.0841
|
-24.552 units on a scale
Standard Error 1.0625
|
SECONDARY outcome
Timeframe: Baseline through week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)
Outcome measures
| Measure |
PLACEBO
n=155 Participants
Orally administered a once-daily dose
|
SPD503
n=154 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment
|
36.1 percentage of subjects
|
50.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Learning and School Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=101 Participants
Orally administered a once-daily dose
|
SPD503
n=97 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13
|
-0.457 units on a scale
Standard Error 0.058
|
-0.572 units on a scale
Standard Error 0.058
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Family Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=101 Participants
Orally administered a once-daily dose
|
SPD503
n=105 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the WFIRS-P Family Domain Score at Week 13
|
-0.314 units on a scale
Standard Error 0.055
|
-0.371 units on a scale
Standard Error 0.054
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=101 Participants
Orally administered a once-daily dose
|
SPD503
n=97 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13
|
-0.376 units on a scale
Standard Error 0.051
|
-0.459 units on a scale
Standard Error 0.050
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=105 Participants
Orally administered a once-daily dose
|
SPD503
n=108 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the WFIRS-P Global Domain Score at Week 13
|
-0.296 units on a scale
Standard Error 0.036
|
-0.347 units on a scale
Standard Error 0.035
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Risk Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=105 Participants
Orally administered a once-daily dose
|
SPD503
n=107 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the WFIRS-P Risk Domain Score at Week 13
|
-0.194 units on a scale
Standard Error 0.027
|
-0.191 units on a scale
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Social Domain consists of 7-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=105 Participants
Orally administered a once-daily dose
|
SPD503
n=108 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the WFIRS-P Social Domain Score at Week 13
|
-0.234 units on a scale
Standard Error 0.046
|
-0.263 units on a scale
Standard Error 0.045
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Child Self-Concept Domain consists of 3-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=104 Participants
Orally administered a once-daily dose
|
SPD503
n=106 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13
|
-0.376 units on a scale
Standard Error 0.067
|
-0.275 units on a scale
Standard Error 0.066
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Life Skills Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=105 Participants
Orally administered a once-daily dose
|
SPD503
n=107 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13
|
-0.328 units on a scale
Standard Error 0.046
|
-0.375 units on a scale
Standard Error 0.045
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Outcome measures
| Measure |
PLACEBO
n=104 Participants
Orally administered a once-daily dose
|
SPD503
n=96 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 13
|
-0.632 units on a scale
Standard Error 0.096
|
-0.841 units on a scale
Standard Error 0.096
|
SECONDARY outcome
Timeframe: weeks 1 through 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Outcome measures
| Measure |
PLACEBO
n=155 Participants
Orally administered a once-daily dose
|
SPD503
n=154 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores at the Last On-Treatment Assessment
|
45.8 percentage of subjects
|
67.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.
Behavior Rating Inventory of Executive Function (BRIEF) is a questionnaire composed of three indices: Global Executive Composite, Behavioral Regulation Index, and Metacognition Index. Items are rated 1 (never), 2 (sometimes), and 3 (often). The Global Executive Composite consists of 72 items with scoring ranging from 72 to 216. The Behavioral Regulation Index score is the total of 28 items and ranges from 28 to 84. The Metacognition Index score is the total of 44 items and ranges from 44 to 132. Lower scores reflect better functioning.
Outcome measures
| Measure |
PLACEBO
n=82 Participants
Orally administered a once-daily dose
|
SPD503
n=88 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13
Global Executive Composite
|
-10.6 units on a scale
Standard Error 1.23
|
-12.9 units on a scale
Standard Error 1.19
|
|
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13
Behavioral Regulation Index
|
-11.5 units on a scale
Standard Error 1.29
|
-12.4 units on a scale
Standard Error 1.25
|
|
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13
Metacognition Index
|
-8.9 units on a scale
Standard Error 1.18
|
-11.6 units on a scale
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Baseline through week 13Population: Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.
The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 item questionnaire scored on a scale from 0 (never) to 4 (always/very often). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.
Outcome measures
| Measure |
PLACEBO
n=105 Participants
Orally administered a once-daily dose
|
SPD503
n=108 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 13
|
-3.7 units on a scale
Standard Error 0.52
|
-4.2 units on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline and week 13Population: Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.
The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Outcome measures
| Measure |
PLACEBO
n=151 Participants
Orally administered a once-daily dose
|
SPD503
n=151 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Last On-Treatment Assessment
|
-7.0 units on a scale
Standard Deviation 9.85
|
-9.1 units on a scale
Standard Deviation 8.11
|
SECONDARY outcome
Timeframe: Through week 16Population: Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.
The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking 'yes' or 'no' on the checklist for each of the events listed.
Outcome measures
| Measure |
PLACEBO
n=155 Participants
Orally administered a once-daily dose
|
SPD503
n=157 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Structure Side-Effect Questionnaire (SSEQ)
Nausea
|
33 participants
|
37 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Vomiting
|
17 participants
|
18 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Diarrhea
|
24 participants
|
29 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Abdominal pain
|
28 participants
|
30 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Decreased appetite
|
42 participants
|
48 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Increased appetite
|
47 participants
|
42 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Headache
|
53 participants
|
76 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Dizziness
|
31 participants
|
49 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Fatigue
|
43 participants
|
65 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Nervousness/anxiety
|
23 participants
|
30 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Insomnia
|
25 participants
|
28 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Somnolence
|
26 participants
|
41 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Depression
|
17 participants
|
14 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Itching
|
9 participants
|
11 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Rash
|
7 participants
|
6 participants
|
|
Structure Side-Effect Questionnaire (SSEQ)
Missed menses
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Through week 16Population: Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.
C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Outcome measures
| Measure |
PLACEBO
n=155 Participants
Orally administered a once-daily dose
|
SPD503
n=154 Participants
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation
|
4 participants
|
5 participants
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal behavior
|
0 participants
|
0 participants
|
Adverse Events
PLACEBO
Serious events: 2 serious events
Other events: 120 other events
Deaths: 0 deaths
SPD503
Serious events: 4 serious events
Other events: 147 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLACEBO
n=155 participants at risk
Orally administered a once-daily dose
|
SPD503
n=157 participants at risk
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/155
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.64%
1/157 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/155
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.64%
1/157 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/155
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.64%
1/157 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.65%
1/155 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.00%
0/157
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/155
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.64%
1/157 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.65%
1/155 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.00%
0/157
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/155
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.64%
1/157 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/155
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.64%
1/157 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.65%
1/155 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.00%
0/157
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Vascular disorders
Withdrawal hypertension
|
0.00%
0/155
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
0.64%
1/157 • Number of events 1
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
Other adverse events
| Measure |
PLACEBO
n=155 participants at risk
Orally administered a once-daily dose
|
SPD503
n=157 participants at risk
Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
6/155 • Number of events 7
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
5.7%
9/157 • Number of events 10
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
7/155 • Number of events 7
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
6.4%
10/157 • Number of events 11
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
13/155 • Number of events 15
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
7.6%
12/157 • Number of events 17
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/155
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
7.6%
12/157 • Number of events 12
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Gastrointestinal disorders
Nausea
|
13.5%
21/155 • Number of events 22
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
12.1%
19/157 • Number of events 22
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
10/155 • Number of events 12
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
5.7%
9/157 • Number of events 9
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
General disorders
Fatigue
|
12.3%
19/155 • Number of events 21
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
22.3%
35/157 • Number of events 41
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
General disorders
Irritability
|
3.9%
6/155 • Number of events 6
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
7.0%
11/157 • Number of events 13
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
9/155 • Number of events 9
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
11.5%
18/157 • Number of events 20
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
12/155 • Number of events 14
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
8.9%
14/157 • Number of events 15
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.5%
21/155 • Number of events 24
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
14.6%
23/157 • Number of events 27
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Metabolism and nutrition disorders
Increased appetite
|
8.4%
13/155 • Number of events 15
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
8.9%
14/157 • Number of events 15
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Nervous system disorders
Dizziness
|
10.3%
16/155 • Number of events 17
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
15.9%
25/157 • Number of events 32
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Nervous system disorders
Dizziness postural
|
1.9%
3/155 • Number of events 3
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
5.1%
8/157 • Number of events 8
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Nervous system disorders
Headache
|
18.1%
28/155 • Number of events 43
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
26.8%
42/157 • Number of events 64
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Nervous system disorders
Sedation
|
1.9%
3/155 • Number of events 3
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
11.5%
18/157 • Number of events 21
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Nervous system disorders
Somnolence
|
21.3%
33/155 • Number of events 39
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
43.9%
69/157 • Number of events 102
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Psychiatric disorders
Insomnia
|
3.9%
6/155 • Number of events 7
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
8.9%
14/157 • Number of events 16
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
8/155 • Number of events 8
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
1.9%
3/157 • Number of events 4
Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
|
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