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NCT04047355 · ClinicalTrials.gov registry record · Phase 2
Propranolol for Challenging Behaviors in Autism
A Phase 2 study of Autism Spectrum Disorder and Aggression, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04047355: Completed Phase 2 study of Autism Spectrum Disorder and Aggression, sponsored by Rutgers, The State University of New Jersey.
NCT04047355 is a Phase 2 study of Autism Spectrum Disorder and Aggression that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 8 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04047355, a Phase 2 study of Autism Spectrum Disorder and Aggression, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Severe challenging behaviors such as aggression and self-injury can cause significant morbidity and decrease the quality of life for individuals with Autism Spectrum Disorders (ASD). There are only two medications (Risperdal and Abilify) rigorously studied and FDA-approved for the treatment of irritability in individuals with ASD. These medications are not always successful and have many short and long-term side effects. Well-designed studies demonstrating efficacy and safety of alternative medication treatment choices are needed. There is preliminary evidence that high-dose propranolol can be effective in individuals with ASD who display severe aggression and have not responded to antipsychotics or mood stabilizers. Concerns regarding the safety of high dose propranolol have limited its clinical application. Well-designed clinical trials demonstrating the efficacy and safety of high dose propranolol will have significant effects on clinical practice and improve the physical and behavioral quality of life for an underserved subset of individuals with ASD. This study will pilot the safety and efficacy of high dose propranolol. The investigators will randomly assign participants to either propranolol or to placebo later crossing each participant over to the other group. As propranolol can cause changes in blood pressure and heart function, each participant will complete initial comprehensive testing to monitor cardiac safety throughout the study. The investigators will be utilizing telemedicine and computer based telemetry to minimize the burden of office visits on the individual and family.
Primary Outcome
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 t
Conditions Studied
Interventions
- DRUG Propranolol
Study Locations (1)
New Jersey
- Department of Pediatrics, Division of Pediatric Neurology, Robert Wood Johnson Medical School - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-02-11 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 2 |
What the finished NCT04047355 record still lists
NCT04047355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Propranolol is the first listed.
NCT04047355 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT04047355 about?
NCT04047355 is a clinical study titled "Propranolol for Challenging Behaviors in Autism". Severe challenging behaviors such as aggression and self-injury can cause significant morbidity and decrease the quality of life for individuals with Autism Spectrum Disorders (ASD). There are only two medications (Risperdal and Abilify) rigorously studied and FDA-approved for the treatment of irrit...
What is the current status of trial NCT04047355?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2021-02-11. Estimated completion is 2023-09-30.
What conditions does trial NCT04047355 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Aggression, Developmental Disability, Self Injurious Behavior, Challenging Behavior.
What interventions are being tested in trial NCT04047355?
The interventions under investigation include: Propranolol (DRUG).
Who is sponsoring clinical trial NCT04047355?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04047355 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04047355's enrollment target sits among peer trials
8 221st of 224 higher than 2 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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