Blood pressure drug may curb aggression in autism

NCT ID NCT07091279

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study tests whether propranolol, a common blood pressure medication, can reduce aggression, self-injury, and severe disruptive behaviors in autistic adolescents and adults. Sixty participants will receive either propranolol or a placebo for 12 weeks, with the option to take propranolol afterward. The goal is to see if the drug is safe and effective for managing these challenging behaviors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Propranolol (a blood pressure medication) taken orally
What this could lead to
If it works, this could offer a new medication option to help manage severe challenging behaviors in autistic individuals.
What could go wrong
This is an early phase 2 trial with only 60 people, so results may not apply to everyone. Propranolol can cause side effects like low blood pressure and slow heart rate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age between 12-40 years. * Clinical best-estimate diagnosis of autism spectrum disorder * Occurrence of severe challenging behaviors, such as aggression, self-injury, and/or severely disruptive or destructive behavior, leading to safety concerns or serious impact of the quality of life, at least weekly over the past 2 months before screening. * Score in the ASD range on the Autism Diagnostic Observation Schedule conducted at the time of study entry or in the past 5 years * Clinical Global Impression Severity scale (CGI-S) score of 4 or above at Baseline * Aberrant Behavior Checklist-2 Irritability/Agitation Subscale Score of 18 or above at Screening. * A resting pulse of greater than 60 and a resting blood pressure of greater than 100/60. * Participant must have a designated study partner who spends a minimum of 5 hours/week with the participant, and can, in the opinion of the investigator, provide a reliable report on the participant's behaviors, symptoms, and complete or supervise at-home safety monitoring and other assessments required during the study * Participants of childbearing potential who are sexually active must agree to practice effective contraception from time of screening through 30 days after their last dose of study drug. Effective contraception is the use of two methods of contraception: hormonal contraceptives or intrauterine device and barrier (i.e., condoms, diaphragm, or cervical cap). * Participant must be able to fully swallow study medication capsule. * English must be primary language for participant. Study partner must be able to consent in English and complete study related form in English. Exclusion Criteria: * Those who are unable to provide informed consent and have no parent/guardian/legally authorized representative to provide informed consent for study enrollment * Change in psychotropic medication or behavioral intervention (except when caused by vocational, habilitation, or school schedule) within two months before randomization. * Asthma or history of any disorder involving bronchoconstriction in the past 5 years. * Cardiovascular history in which the use of propranolol at high doses would be contraindicated, as determined by consulting cardiologist (such as AV block, sick sinus syndrome, valvular pathologies, cardiomyopathies, or vascular disease). * Uncontrolled seizure disorder (a seizure within the past year and/or changes in seizure medication in the previous six months). * Diabetes mellitus * History of lactose intolerance that requires the potential participant to abstain from all dairy products or to take lactase supplements. * Medical history of renal or hepatic impairment. * Medical history of hypoglycemia * Inability to provide blood testing when there is a medical indication for blood testing to allow clinical safety determination by the study safety physician * Depressive episode currently or within the previous six months * History of allergy or adverse reaction to propranolol or another beta-blocker * Current use of any of the following: propafenone, quinidine, amiodarone, lidocaine, digitalis glycosides, calcium channel blockers, ACE inhibitors, clonidine, alpha blockers, reserpine, inotropic agents (epinephrine), isoproterenol and dobutamine, nonsteroidal anti-inflammatory drugs (indomethacin), antidepressants (MAO inhibitors, tricyclics), anesthetic agents (methoxyflurane, trichloroethylene), warfarin, neuroleptics (haloperidol), thyroxine, alcohol * Any other medical disorder or medication which would contraindicate the use of propranolol. * Is judged to be inappropriate for the study for any reason by the Investigator * Has recently participated in another investigational medication study or device study within last 3 months * Participant is unable to complete blood pressure or ECG safety assessments * If female, is pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Aggression autism autism spectrum disorder disruptive behavior disorder Problem Behavior Self-Injurious Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Autism and the Developing Brain

    RECRUITING

    White Plains, New York, 10605, United States

  • New York State Institute for Basic Research (IBR)

    RECRUITING

    Staten Island, New York, 10314, United States

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