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New treatment option for Autism Spectrum Disorder
Official title Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
ClinicalTrials.gov ID: NCT07091279
What this study is testing
What is Propranolol?
Propranolol is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for autism spectrum disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if propranolol can help reduce challenging behaviors associated with Autism Spectrum Disorder, including aggression, self-injury, and severe disruptive behaviors. Participants will be randomly assigned to receive either propranolol or a placebo (a look-alike substance that contains no drug) daily for 12 weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 40
You may be able to join if
- 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...
- 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
You likely can't join if
- Those who are unable to provide informed consent and have no parent/guardian/legally authorized representative to provide informed consent for study...
- Change in psychotropic medication or behavioral intervention (except when caused by vocational, habilitation, or school schedule) within two months...
- 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...
- Uncontrolled seizure disorder (a seizure within the past year and/or changes in seizure medication in the previous six months).
- Diabetes mellitus
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Staten Island, New York, United States
- White Plains, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Staten Island, New York, United States; White Plains, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.