Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 12 and 40 years old.
• You have been diagnosed with autism spectrum disorder (ASD) based on a doctor's best clinical judgment.
• You have had serious challenging behaviors — such as aggression, self-harm, or severely disruptive or destructive behavior — that cause safety concerns or significantly affect quality of life, happening at least once a week over the past 2 months.
• You have had a formal autism assessment (called the ADOS) that placed you in the autism range, either recently or within the past 5 years.
• A doctor has rated your overall condition as moderately severe or above on a standard severity scale at the start of the study.
• Your score on a standard behavior checklist measuring irritability and agitation is 18 or above at the screening visit.
• Your resting heart rate is above 60 beats per minute and your resting blood pressure is above 100/60.
• You have someone in your life (a study partner) who spends at least 5 hours per week with you, can reliably report on your behaviors and symptoms, and can help with safety monitoring and other tasks required during the study.
• If you are someone who could become pregnant and are sexually active, you must agree to use two forms of effective contraception from screening through 30 days after your last dose of study medication.
• You are able to swallow the study medication capsule whole.
• English is your primary language, and your study partner can read, consent, and complete study forms in English.

Who may not be able to join:

• You cannot give informed consent yourself and do not have a parent, guardian, or legally authorized representative who can consent on your behalf.
• Your psychiatric medications or behavioral treatment program have changed within the past two months before joining the study (unless the change was due to a school, vocational, or daily schedule change).
• You have asthma or any condition involving airway narrowing (bronchoconstriction) in the past 5 years.
• You have a heart condition that would make taking high doses of propranolol unsafe, as determined by a heart specialist (confirm with trial site).
• You have a seizure disorder that is not well controlled — meaning you have had a seizure in the past year or your seizure medication has changed in the past six months.
• You have diabetes.
• You have lactose intolerance that requires you to completely avoid all dairy products or take lactase supplements.
• You have a history of kidney or liver problems.
• You have a history of low blood sugar (hypoglycemia).
• You are unable to have blood drawn when the study's safety doctor determines it is medically necessary.
• You are currently experiencing, or have experienced in the past six months, a depressive episode.
• You have had an allergic reaction or a bad reaction to propranolol or any other beta-blocker medication in the past.
• You are currently taking certain medications, including (but not limited to): propafenone, quinidine, amiodarone, lidocaine, digoxin, calcium channel blockers, ACE inhibitors, clonidine, alpha blockers, reserpine, epinephrine, isoproterenol, dobutamine, indomethacin, MAO inhibitors, tricyclic antidepressants, certain anesthetic agents, warfarin, haloperidol, thyroxine, or alcohol (confirm full medication list with trial site).
• You have any other medical condition or take any other medication that would make using propranolol unsafe (confirm with trial site).
• The study investigator decides for any reason that the study is not right for you.
• You have taken part in another clinical drug or device study within the past 3 months.
• You are unable to have your blood pressure checked or have an ECG (heart tracing) done as part of safety monitoring.
• You are currently pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.