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Propranolol for Autism
Phase 2
Waitlist Available
Led By Barbie Zimmerman-Bier, M.D.
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly through study completion, up to 7 months
Awards & highlights
Summary
This trial will help to determine if propranolol is a safe and effective treatment for severe challenging behaviors in ASD.
Who is the study for?
This trial is for New Jersey residents aged 12-30 with Autism Spectrum Disorder who exhibit severe aggression or self-injury and haven't improved enough on two psychotropic drugs, including an antipsychotic. Participants must have a confirmed autism diagnosis, be medically and cardiac cleared, and not have uncontrolled seizures or conditions that propranolol could worsen.
What is being tested?
The study tests high-dose propranolol's safety and effectiveness against challenging behaviors in autism compared to a placebo. Participants will switch between the drug and placebo during the trial. Cardiac safety is monitored through initial testing followed by remote check-ups to reduce office visits.
What are the potential side effects?
Propranolol can cause changes in blood pressure, heart function issues, may affect breathing in people with bronchial disorders like asthma, and isn't safe for those with certain heart diseases or diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly through study completion, up to 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly through study completion, up to 7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Aberrant Behavior Checklist (ABC-C)
Secondary study objectives
Change in Clinical Global Impression Scale (CGI)
Change in Modified Overt Aggression Scale (IBR-MOAS)
Change in Questions About Behavior Function (QABF)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: Propranolol firstExperimental Treatment1 Intervention
Participants randomly assigned to this group will receive Propranolol first. After the washout period, they will receive Placebo.
Propranolol will be given in liquid or pill form.
Group II: Group B: Placebo firstPlacebo Group1 Intervention
Participants randomly assigned to this group will receive Placebo first. After the washout period, they will receive Propranolol.
Placebo will look identical to the study drug Propranolol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol
FDA approved
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,376 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
171 Patients Enrolled for Autism Spectrum Disorder
New Jersey Governor's Council for Medical Research and Treatment of AutismUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
New York State Institute for Basic ResearchOTHER_GOV
6 Previous Clinical Trials
958 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
259 Patients Enrolled for Autism Spectrum Disorder
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I engage in self-harm that causes tissue damage.I engage in self-harm that causes tissue damage.I have shown physical aggression towards others.My challenging behaviors match my emotions, as confirmed by a psychiatrist.I experience intense anger episodes with screaming or property damage.I have been diagnosed with autism confirmed by ADOS or SCQ tests.My condition is considered severely debilitating or among the most extremely ill.I've tried at least two mental health medications, including an antipsychotic, without full success.I am not taking medications like clonidine or digoxin that affect blood pressure.I have shown physical aggression towards others.I experience intense anger episodes that disrupt my daily life.My aggressive behaviors match my feelings of anger or rage, as confirmed by a psychiatrist.I have had a seizure or changed my seizure medication in the last 6 months.I have diabetes or have had ketoacidosis before.I have asthma or a history of asthma.My heart and overall health are cleared by a doctor.I do not have any conditions or take medications that would make it unsafe for me to use propranolol.I am allergic to or have had a bad reaction to propranolol.I am between 12 and 30 years old and live in New Jersey.I exhibit one or more challenging behaviors.I don't have heart conditions that prevent me from taking high doses of propranolol.I experience intense anger episodes that disrupt my daily life.
Research Study Groups:
This trial has the following groups:- Group 1: Group B: Placebo first
- Group 2: Group A: Propranolol first
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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