Trial Outcomes & Findings for Ecopipam Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease (NCT NCT01751802)
NCT ID: NCT01751802
Last Updated: 2024-04-22
Results Overview
The primary endpoint is the BPI (SIB subscales - total for frequency and severity) as assessed by the caregiver. BPI Self-Injurious Behavior Subscale ranges from 0 to 45, with higher scores indicating more self-injurious behavior.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9 participants
Primary outcome timeframe
Baseline, end of period 1 (6 weeks), end of period 2 (12 weeks), end of period 3 (18 weeks),
Results posted on
2024-04-22
Participant Flow
Participant milestones
| Measure |
Ecopipam Then Placebo Then Ecopipam
Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
|
Placebo Then Ecopipam Then Placebo
Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
Completed Period 1
|
2
|
4
|
|
Overall Study
Completed Period 2
|
2
|
1
|
|
Overall Study
Completed Period 3
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Ecopipam Then Placebo Then Ecopipam
Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
|
Placebo Then Ecopipam Then Placebo
Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
Baseline Characteristics
Ecopipam Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease
Baseline characteristics by cohort
| Measure |
Ecopipam Then Placebo Then Ecopipam
n=5 Participants
Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
|
Placebo Then Ecopipam Then Placebo
n=4 Participants
Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.8 years
n=5 Participants
|
9.8 years
n=7 Participants
|
10.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Weight
|
28.3 kg
n=5 Participants
|
21.9 kg
n=7 Participants
|
25.4 kg
n=5 Participants
|
|
BMI
|
15.6 kg/m^2
n=5 Participants
|
13.8 kg/m^2
n=7 Participants
|
14.8 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, end of period 1 (6 weeks), end of period 2 (12 weeks), end of period 3 (18 weeks),Population: All participants who completed the BPI-Self Injurious Behavior survey for 3 or more time points
The primary endpoint is the BPI (SIB subscales - total for frequency and severity) as assessed by the caregiver. BPI Self-Injurious Behavior Subscale ranges from 0 to 45, with higher scores indicating more self-injurious behavior.
Outcome measures
| Measure |
Subject #1: Ecopipam Then Placebo Then Ecopipam
n=1 Participants
Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
|
Subject #2: Ecopipam Then Placebo Then Ecopipam
n=1 Participants
Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
|
Subject #3: Placebo Then Ecopipam Then Placebo
n=1 Participants
Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
|
Subject #4: Placebo Then Ecopipam Then Placebo
n=1 Participants
Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
|
|---|---|---|---|---|
|
Behavior Problems Inventory - Self-Injurious Behavior Subscale
BPI Self-Injurious Behavior Subscale, Baseline
|
26 scores on a scale
|
10 scores on a scale
|
78 scores on a scale
|
27 scores on a scale
|
|
Behavior Problems Inventory - Self-Injurious Behavior Subscale
BPI Self-Injurious Behavior Subscale, 6 weeks
|
24.1 scores on a scale
|
4.3 scores on a scale
|
58.3 scores on a scale
|
22.6 scores on a scale
|
|
Behavior Problems Inventory - Self-Injurious Behavior Subscale
BPI Self-Injurious Behavior Subscale, 12 weeks
|
25.2 scores on a scale
|
11.6 scores on a scale
|
21.5 scores on a scale
|
16.0 scores on a scale
|
|
Behavior Problems Inventory - Self-Injurious Behavior Subscale
BPI Self-Injurious Behavior Subscale, 18 weeks
|
21 scores on a scale
|
6.6 scores on a scale
|
28.7 scores on a scale
|
NA scores on a scale
participant did not complete subscale survey at 18 wks
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks, 18 weeksPopulation: 0 participants analyzed because data are not reliable
The secondary objectives of this study are to assess the effect of withdrawal and maintenance of ecopipam's effects in subjects with LND. Measured by the number of participants whose score changes significantly from baseline on ecopipam or placebo
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Total duration over which participants recieved double-blind ecopipam or placebo, up to 6 or 12 weeksPopulation: All participants who received at least one dose
An additional objective of the study is to assess the safety of ecopipam in subjects with LND for up to 52 weeks. Total number of serious and non-serious adverse events experienced by participants while receiving ecopipam or placebo. For additional detail, see Adverse Events
Outcome measures
| Measure |
Subject #1: Ecopipam Then Placebo Then Ecopipam
n=9 Participants
Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
|
Subject #2: Ecopipam Then Placebo Then Ecopipam
n=6 Participants
Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
|
Subject #3: Placebo Then Ecopipam Then Placebo
Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
|
Subject #4: Placebo Then Ecopipam Then Placebo
Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight \> 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
|
|---|---|---|---|---|
|
Safety Summary of Ecopipam in Patients With Lesch-Nyhan Disease: Total Number of Serious and Non-Serious Adverse Events Experienced During 3 Double-blind Crossover Periods
Non-Serious
|
42 adverse events
|
7 adverse events
|
—
|
—
|
|
Safety Summary of Ecopipam in Patients With Lesch-Nyhan Disease: Total Number of Serious and Non-Serious Adverse Events Experienced During 3 Double-blind Crossover Periods
Serious
|
2 adverse events
|
1 adverse events
|
—
|
—
|
Adverse Events
Ecopipam
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ecopipam
n=9 participants at risk
Active substance being tested, orally once a day at bedtime
Ecopipam: Antagonist of the dopamine D1 receptor
|
Placebo
n=6 participants at risk
Inactive substance being tested, orally once a day at bedtime
Placebo: Placebo for Ecopipam
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/9 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
16.7%
1/6 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Nervous system disorders
Dystonic crisis
|
11.1%
1/9 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Psychiatric disorders
Unusual somnolence
|
11.1%
1/9 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
Other adverse events
| Measure |
Ecopipam
n=9 participants at risk
Active substance being tested, orally once a day at bedtime
Ecopipam: Antagonist of the dopamine D1 receptor
|
Placebo
n=6 participants at risk
Inactive substance being tested, orally once a day at bedtime
Placebo: Placebo for Ecopipam
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • Number of events 2 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Psychiatric disorders
Agitation
|
22.2%
2/9 • Number of events 2 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
16.7%
1/6 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Investigations
Body temperature increased
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/9 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
16.7%
1/6 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Psychiatric disorders
Compulsive lip biting
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 2 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Psychiatric disorders
Depressed mood
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Psychiatric disorders
Depression
|
33.3%
3/9 • Number of events 3 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Gastrointestinal disorders
Dysphagia
|
55.6%
5/9 • Number of events 5 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/9 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
16.7%
1/6 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Nervous system disorders
Dystonia
|
22.2%
2/9 • Number of events 2 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Blood and lymphatic system disorders
Eosinophilia
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Number of events 2 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
16.7%
1/6 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Injury, poisoning and procedural complications
Lip injury
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
General disorders
Mucosal inflammation
|
0.00%
0/9 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
16.7%
1/6 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Renal and urinary disorders
Nephrolithiasis
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Nervous system disorders
Opisthotonus
|
22.2%
2/9 • Number of events 2 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Infections and infestations
Oral candidiasis
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
General disorders
Pyrexia
|
0.00%
0/9 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
16.7%
1/6 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Psychiatric disorders
Self injurious behaviour
|
44.4%
4/9 • Number of events 4 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
16.7%
1/6 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Nervous system disorders
Somnolence
|
55.6%
5/9 • Number of events 5 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Investigations
Transaminases increased
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
0.00%
0/6 • adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Adverse events were collected for 3 double-blind periods
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place