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Beta Blocker

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

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly through study completion, up to 7 months for reporting.

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 more

Awards & Highlights

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.

Trial 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

Do I qualify?Apply below to find out