Propranolol for Autism

Overseen By Eric London, M.D.

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Antipsychotics, Psychotropics

Must not be taking: Clonidine, Guanfacine, Digoxin

Disqualifiers: Asthma, Cardiac diseases, Seizure, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of high-dose propranolol, a beta-blocker medication, for individuals with Autism Spectrum Disorders (ASD) who experience severe behaviors such as aggression and self-injury. Current medications often prove ineffective and can cause serious side effects, so researchers hope propranolol might offer a better alternative. Participants will receive either propranolol or a placebo (a substance with no therapeutic effect) and will switch after a set period. The trial seeks individuals in New Jersey, aged 12-30, who have tried other medications without success and exhibit challenging behaviors like self-injury or aggression. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take clonidine, guanfacine, digoxin, or other medications affecting blood pressure. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that high-dose propranolol is likely to be safe for humans?

Research has shown that propranolol is usually safe for use. It is often prescribed for high blood pressure and heart rhythm issues. However, high doses can impact blood pressure and heart function, making careful monitoring essential. The FDA has not confirmed propranolol's safety for these uses in children, though it is approved for other conditions in adults. This trial tests high doses, with safety checks in place to protect participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for autism focus on behavioral therapies and medications targeting symptoms like irritability with drugs such as risperidone or aripiprazole. However, propranolol is unique because it works differently, targeting the brain's response to stress and anxiety. Propranolol is a beta-blocker, traditionally used for heart conditions, but it may help improve social interaction and communication in people with autism by reducing anxiety. Researchers are excited about this potential because it could offer a new way to enhance daily functioning and quality of life for those with autism, addressing areas that current medications don't specifically target.

What evidence suggests that propranolol might be an effective treatment for severe challenging behaviors in autism?

Research has shown that propranolol might help reduce severe aggression in people with Autism Spectrum Disorder (ASD). In one study, participants who took propranolol showed about a 50% improvement in their symptoms compared to those who took a placebo. Another study found a 37% decrease in aggressive behaviors with propranolol use. Although this was a smaller study, these early results suggest that propranolol could be a promising option for managing difficult behaviors in people with ASD. In this trial, participants will be randomly assigned to receive either propranolol first or a placebo first, with a washout period in between. However, more research is needed to confirm these findings. ^{6 7 8 9 10}

Who Is on the Research Team?

Barbie Zimmerman-Bier, M.D.

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

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 engage in self-harm that causes tissue damage.

I have shown physical aggression towards others.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Cognitive and adaptive information is collected before randomization

2 weeks

1 visit (in-person)

Treatment Phase A

Participants receive either Propranolol or Placebo with weekly monitoring

12 weeks

Weekly telemedicine visits

Washout

Participants undergo a washout period before crossover

2 weeks

Treatment Phase B

Participants crossover to receive the alternate treatment (Propranolol or Placebo)

12 weeks

Weekly telemedicine visits

Open-label Extension

Participants continue in an open-label phase with Propranolol

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Propranolol

Trial Overview 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.

How Is the Trial Designed?

Group I: Group A: Propranolol first Experimental Treatment 1 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 first Placebo Group 1 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:

• High blood pressure
• Angina pectoris
• Heart rhythm disorders
• Migraine prophylaxis
• Essential tremor
• Performance anxiety

Approved in European Union as Propranolol for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Essential tremor
• Anxiety

Approved in Canada as Propranolol for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Essential tremor
• Anxiety

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

New Jersey Governor's Council for Medical Research and Treatment of Autism

Collaborator

Trials

2

Recruited

40+

New York State Institute for Basic Research

Collaborator

Trials

7

Recruited

960+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39174017/

High-Dose Propranolol for Severe and Chronic Aggression ... Conclusion: These results suggest that propranolol is an effective option in decreasing aggression in individuals with ASD. As this was a small ...

2. bhcsmt.com bhcsmt.com/resources/autism/Propranolol%20for%20ASD.pdf

Propranolol for treating emotional, behavioural, autonomic ... Given the lack of good quality clinical trials, randomised controlled trials are warranted to explore the efficacy of propranolol in managing EBAD in ASD.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460740/

High-Dose Propranolol for Severe and Chronic Aggression in ... The CGI-I indicated a 50% reduction in symptoms in the propranolol phase, while the ABC-I indicated a 37% reduction in comparison to placebo.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07091279

NCT07091279 | Propranolol for Aggression, Self-Injury ... The goal of this clinical trial is to learn if propranolol can help reduce challenging behaviors associated with Autism Spectrum Disorder, ...

5. cdmrp.health.mil cdmrp.health.mil/arp/research_highlights/22Beversdorf_highlight.aspx

Using Propranolol to Treat the Core Symptoms of Autism ... In a small study, Dr. David Beversdorf and his team previously reported a significant beneficial effect from a single dose of propranolol on a ...

6. webmd.com webmd.com/drugs/2/drug-10404-9168/propranolol-oral/propranolol-oral/details

Propranolol (Inderal LA, Innopran XL, others) - Uses, Side ... Propranolol can lower blood pressure and may increase the risk for stroke in people with PHACE syndrome that have abnormal blood vessels in the ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf

PRESCRIBING INFORMATION InnoPran XL (propranolol ... The plasma levels of propranolol showed dose-proportional increases after single and multiple administrations of 80-, 120-, and 160-mg of Innopran XL. At steady ...

8. go.drugbank.com go.drugbank.com/drugs/DB00571

Propranolol: Uses, Interactions, Mechanism of Action Propranolol is a non-selective beta adrenergic antagonist used to treat hypertension, angina, atrial fibrillation, myocardial infarction, ...

9. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac196ff5-9215-402b-bc57-69aa87f8bade

INDERAL XL- propranolol hydrochloride capsule, extended ... Safety and effectiveness of propranolol in pediatric patients have not been established. 8.5 Geriatric Use. Clinical studies of INDERAL XL did not include ...

10. drugs.com drugs.com/propranolol.html

Propranolol: Uses, Dosage, Side Effects, Warnings Propranolol is used to treat tremors, angina (chest pain), hypertension (high blood pressure), heart rhythm disorders, and other heart or circulatory ...