Propranolol for Autism

Recruiting in Palo Alto (17 mi)

Overseen ByBarbie Zimmerman-Bier, M.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I engage in self-harm that causes tissue damage.

I have shown physical aggression towards others.

+13 more

Exclusion Criteria

Pregnancy.

I am not taking medications like clonidine or digoxin that affect blood pressure.

I have had a seizure or changed my seizure medication in the last 6 months.

+5 more

Participant Groups

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.

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.

Propranolol is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Inderal for: