Trial Outcomes & Findings for Propranolol for Challenging Behaviors in Autism (NCT NCT04047355)
NCT ID: NCT04047355
Last Updated: 2025-06-04
Results Overview
The Aberrant Behavior Checklist--Community (ABC-C) is a behavior checklist that measures drug and other treatment effects in people with intellectual and developmental disabilities. It is made up of five subscales, including Irritability, Lethargy, Inappropriate Speech, Hyperactivity, and Stereotypy based on 58 items that describe various behavioral problems. Each item is scored on a Likert scale: 1 = not at all a problem, to 3 = problem is severe in degree. The Irritability Subscale served as the primary dependent measure. The minimum score on the Irritability Subscale is 0 and the maximum score is 45. Lower scores represent better outcome.
COMPLETED
PHASE2
8 participants
Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.
2025-06-04
Participant Flow
This was a crossover study. 6 subjects underwent both experimental phases (i.e., crossover design). 3 subjects underwent Propranolol first, then Placebo while the remaining 3 subjects underwent Placebo first, then Propranolol.
Participant milestones
| Measure |
Group A: Propranolol First, Then Placebo Second
First Propranolol, then Placebo, then Open Label Propranolol.
Participants randomly assigned to this group received Propranolol first. Titration time period and maximum dose were flexible based on individual response. Maximum dose was up to 200 mg TID for 6 weeks.
After the washout period, they received Placebo in the same fashion.
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Group B: Placebo First, Then Propranolol Second
First Placebo, then Propranolol, then Open Label Propranolol.
Participants randomly assigned to this group received Placebo first. After the washout period, they received Propranolol. Titration time period and maximum dose were flexible based on individual response. Maximum dose was up to 200 mg TID for 6 weeks.
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|---|---|---|
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Overall Study
STARTED
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3
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3
|
|
Overall Study
COMPLETED
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3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propranolol for Challenging Behaviors in Autism
Baseline characteristics by cohort
| Measure |
Group A: First Propranolol, Then Placebo
n=3 Participants
Participants randomly assigned to this group received Propranolol first. After the washout period, they received Placebo.
|
Group B: First Placebo, Then Propranolol
n=3 Participants
Participants randomly assigned to this group received Placebo first. After the washout period, they received Propranolol.
|
Total
n=6 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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15 years
n=5 Participants
|
15 years
n=7 Participants
|
15 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.Population: Participants served as their own controls. Each participant received both Propranolol and Placebo. The treatment order was randomized.
The Aberrant Behavior Checklist--Community (ABC-C) is a behavior checklist that measures drug and other treatment effects in people with intellectual and developmental disabilities. It is made up of five subscales, including Irritability, Lethargy, Inappropriate Speech, Hyperactivity, and Stereotypy based on 58 items that describe various behavioral problems. Each item is scored on a Likert scale: 1 = not at all a problem, to 3 = problem is severe in degree. The Irritability Subscale served as the primary dependent measure. The minimum score on the Irritability Subscale is 0 and the maximum score is 45. Lower scores represent better outcome.
Outcome measures
| Measure |
Propranolol Phase
n=6 Participants
All 6 participants received propranolol either as the first treatment or the second treatment.
|
Placebo Phase
n=6 Participants
All 6 participants received placebo either as the first treatment or the second treatment.
|
|---|---|---|
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Aberrant Behavior Checklist--Community (ABC-C) Irritability Subscale Scores
|
14.0 score on a scale
Interval 6.25 to 16.5
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18.50 score on a scale
Interval 12.25 to 27.25
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SECONDARY outcome
Timeframe: Titration schedule varied based on individual response; it was not predetermined. On average, Placebo was 8 wks and Propranolol was 11 wks, including titration. The last Baseline score and the last scores from Placebo and Propranolol phases were analyzed.Population: Participants served as their own controls. Each participant received both Propranolol and Placebo. The treatment order was randomized.
The Clinical Global Impression Improvement (CGI-I) scale is used by the study psychiatrist to judge the overall clinical condition relative to baseline using the same scale as the CGI-S. The study psychiatrist will rate the improvement from baseline. The CGI consists of a 7-point subjective scale assessing symptom. Lower scores represent better outcomes. Scores of 1, 2, and 3 represent normal, some presence of symptoms, and mild behavior, respectively. A score of 4 represents moderate behavior. Scores of 5, 6, and 7 represent marked, severe, and among the most severe behavior, respectively.
Outcome measures
| Measure |
Propranolol Phase
n=6 Participants
All 6 participants received propranolol either as the first treatment or the second treatment.
|
Placebo Phase
n=6 Participants
All 6 participants received placebo either as the first treatment or the second treatment.
|
|---|---|---|
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Clinical Global Impression Improvement (CGI-I) Scale
|
2.00 score on a scale
Interval 1.75 to 3.5
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5.50 score on a scale
Interval 3.75 to 6.0
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Adverse Events
Propranolol
Placebo
Open Label
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Propranolol
n=6 participants at risk
Subjects who received Blinded Propranolol
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Placebo
n=6 participants at risk
Subjects who received Placebo
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Open Label
n=5 participants at risk
Subjects who received Open Label Propranolol
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|---|---|---|---|
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Nervous system disorders
Lethargy
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16.7%
1/6 • Number of events 1 • Weekly over the entire double-blind portion of the study. Exact duration varied per participant due to individualized titration periods (approximately 5-7 months based on individual titration schedule). The open label phase was two months.
|
0.00%
0/6 • Weekly over the entire double-blind portion of the study. Exact duration varied per participant due to individualized titration periods (approximately 5-7 months based on individual titration schedule). The open label phase was two months.
|
0.00%
0/5 • Weekly over the entire double-blind portion of the study. Exact duration varied per participant due to individualized titration periods (approximately 5-7 months based on individual titration schedule). The open label phase was two months.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Weekly over the entire double-blind portion of the study. Exact duration varied per participant due to individualized titration periods (approximately 5-7 months based on individual titration schedule). The open label phase was two months.
|
0.00%
0/6 • Weekly over the entire double-blind portion of the study. Exact duration varied per participant due to individualized titration periods (approximately 5-7 months based on individual titration schedule). The open label phase was two months.
|
0.00%
0/5 • Weekly over the entire double-blind portion of the study. Exact duration varied per participant due to individualized titration periods (approximately 5-7 months based on individual titration schedule). The open label phase was two months.
|
Additional Information
J. Helen Yoo, Ph.D.
New York State Institute for Basic Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place