Trial Outcomes & Findings for Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder (NCT NCT01238575)
NCT ID: NCT01238575
Last Updated: 2020-03-31
Results Overview
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.
COMPLETED
PHASE4
62 participants
Week 8
2020-03-31
Participant Flow
81 total patients screened. 13 ineligible. 6 Declined
Participant milestones
| Measure |
Extended-release Guanfacine
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
Inactive Placebo
placebo: Administered for up to 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Extended-release Guanfacine
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
Inactive Placebo
placebo: Administered for up to 8 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Baseline characteristics by cohort
| Measure |
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.44 years
STANDARD_DEVIATION 2.28 • n=5 Participants
|
8.39 years
STANDARD_DEVIATION 2.23 • n=7 Participants
|
8.4 years
STANDARD_DEVIATION 2.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Hyperactivity Subscale
|
29.7 units on a scale
Interval 25.82 to 33.53
|
19.3 units on a scale
Interval 15.33 to 23.33
|
SECONDARY outcome
Timeframe: Week 8The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
ADHD Rating Scale - Total
|
38.0 units on a scale
Interval 34.44 to 41.63
|
25.2 units on a scale
Interval 21.44 to 29.03
|
SECONDARY outcome
Timeframe: 8 weeksThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. It is a 58 item checklist which takes about 10 - 15 minutes to complete. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech. The higher the number of items (score), the greater the amount of symptoms. Scores can range from 0 to 45.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Irritability Subscale
|
16.1 units on a scale
Interval 12.68 to 19.54
|
13.5 units on a scale
Interval 10.01 to 17.06
|
SECONDARY outcome
Timeframe: 8 weeksThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Social Withdrawal Subscale
|
8.6 units on a scale
Interval 6.1 to 11.02
|
9.8 units on a scale
Interval 7.26 to 12.27
|
SECONDARY outcome
Timeframe: 8 weeksThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Sterotypy Subscale
|
5.9 units on a scale
Interval 4.37 to 7.49
|
3.6 units on a scale
Interval 2.03 to 5.26
|
SECONDARY outcome
Timeframe: 8 weeksThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Inappropriate Speech Subscale
|
5.99 units on a scale
Interval 4.5 to 6.97
|
4.2 units on a scale
Interval 3.24 to 5.26
|
SECONDARY outcome
Timeframe: 8 weeksThe ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
ADHD Rating Scale - Inattention Subscale
|
19.5 units on a scale
Interval 17.52 to 21.56
|
14.7 units on a scale
Interval 12.55 to 16.78
|
SECONDARY outcome
Timeframe: 8 weeksThe ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
ADHD Rating Scale - Hyperactivity Subscale
|
18.7 units on a scale
Interval 16.66 to 20.69
|
10.6 units on a scale
Interval 8.5 to 12.75
|
SECONDARY outcome
Timeframe: BaselineThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Hyperactivity Subscale
|
34.25 units on a scale
Interval 31.74 to 36.76
|
34.4 units on a scale
Interval 32.4 to 36.4
|
SECONDARY outcome
Timeframe: BaselineThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. Scores for this subscale can range from 0 to 45.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Irritability Subscale
|
18.06 units on a scale
Interval 14.54 to 21.58
|
20.3 units on a scale
Interval 16.79 to 23.81
|
SECONDARY outcome
Timeframe: BaselineThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Social Withdrawal Subscale
|
12.06 units on a scale
Interval 8.71 to 15.41
|
13.6 units on a scale
Interval 10.08 to 17.12
|
SECONDARY outcome
Timeframe: BaselineThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Sterotypy Subscale
|
9.31 units on a scale
Interval 7.31 to 11.32
|
8.53 units on a scale
Interval 6.41 to 10.66
|
SECONDARY outcome
Timeframe: BaselineThe Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
Aberrant Behavior Checklist Inappropriate Speech Subscale
|
6.84 units on a scale
Interval 5.63 to 8.06
|
6.33 units on a scale
Interval 5.02 to 7.65
|
SECONDARY outcome
Timeframe: BaselineThe ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
ADHD Rating Scale - Inattention Subscale
|
20.41 units on a scale
Interval 18.75 to 22.06
|
20.53 units on a scale
Interval 19.17 to 21.9
|
SECONDARY outcome
Timeframe: BaselineThe ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
ADHD Rating Scale - Hyperactivity Subscale
|
19.5 units on a scale
Interval 17.71 to 21.29
|
19.00 units on a scale
Interval 17.38 to 20.62
|
SECONDARY outcome
Timeframe: BaselineThe ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.
Outcome measures
| Measure |
Inactive Placebo
n=32 Participants
placebo: Administered for up to 8 weeks.
|
Extended-release Guanfacine
n=30 Participants
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
|---|---|---|
|
ADHD Rating Scale - Total
|
39.91 units on a scale
Interval 37.5 to 42.32
|
39.53 units on a scale
Interval 37.33 to 41.73
|
Adverse Events
Extended-release Guanfacine
Inactive Placebo
Serious adverse events
| Measure |
Extended-release Guanfacine
n=30 participants at risk
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
Inactive Placebo
n=32 participants at risk
placebo: Administered for up to 8 weeks.
|
|---|---|---|
|
Psychiatric disorders
Aggressive
|
3.3%
1/30
|
0.00%
0/32
|
Other adverse events
| Measure |
Extended-release Guanfacine
n=30 participants at risk
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
|
Inactive Placebo
n=32 participants at risk
placebo: Administered for up to 8 weeks.
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
86.7%
26/30
|
9.4%
3/32
|
|
General disorders
Fatigue
|
63.3%
19/30
|
9.4%
3/32
|
|
General disorders
Decreased Appetite
|
43.3%
13/30
|
6.2%
2/32
|
|
General disorders
Emotional/tearful
|
40.0%
12/30
|
9.4%
3/32
|
|
Gastrointestinal disorders
Dry Mouth
|
40.0%
12/30
|
3.1%
1/32
|
|
General disorders
Irritability
|
36.7%
11/30
|
9.4%
3/32
|
|
Psychiatric disorders
Anxiety
|
30.0%
9/30
|
3.1%
1/32
|
|
Nervous system disorders
Headache
|
30.0%
9/30
|
18.8%
6/32
|
|
General disorders
Increased Energy
|
30.0%
9/30
|
18.8%
6/32
|
|
Psychiatric disorders
Mid sleep awakening
|
30.0%
9/30
|
6.2%
2/32
|
|
Gastrointestinal disorders
Stomachache
|
26.7%
8/30
|
12.5%
4/32
|
|
Gastrointestinal disorders
Constipation
|
23.3%
7/30
|
6.2%
2/32
|
|
Psychiatric disorders
Increased Repetitive Behavior
|
16.7%
5/30
|
9.4%
3/32
|
|
Psychiatric disorders
Aggression
|
16.7%
5/30
|
6.2%
2/32
|
|
Psychiatric disorders
Depressed Mood
|
13.3%
4/30
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough/Congestion
|
13.3%
4/30
|
12.5%
4/32
|
|
Psychiatric disorders
Self-injury
|
10.0%
3/30
|
0.00%
0/32
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30
|
6.2%
2/32
|
|
Psychiatric disorders
Trouble Falling Asleep
|
10.0%
3/30
|
6.2%
2/32
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30
|
6.2%
2/32
|
|
Psychiatric disorders
Silly
|
10.0%
3/30
|
15.6%
5/32
|
|
General disorders
Weakness
|
10.0%
3/30
|
3.1%
1/32
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30
|
0.00%
0/32
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30
|
9.4%
3/32
|
|
Gastrointestinal disorders
Increased Appetite
|
6.7%
2/30
|
6.2%
2/32
|
|
Psychiatric disorders
Excessive Talking
|
6.7%
2/30
|
28.1%
9/32
|
|
Eye disorders
Blurred Vision
|
6.7%
2/30
|
0.00%
0/32
|
|
Skin and subcutaneous tissue disorders
Skin rash/Eczema
|
6.7%
2/30
|
12.5%
4/32
|
|
Psychiatric disorders
Nightmares
|
6.7%
2/30
|
0.00%
0/32
|
|
Renal and urinary disorders
Enuresis
|
6.7%
2/30
|
6.2%
2/32
|
|
Nervous system disorders
Motor Tics
|
3.3%
1/30
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Skin Picking
|
3.3%
1/30
|
9.4%
3/32
|
|
General disorders
Fever
|
3.3%
1/30
|
9.4%
3/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place