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Propranolol for Autism Spectrum Disorder
N/A
Waitlist Available
Led By David Q Beversdorf, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Summary
This trial tests whether propranolol, a calming medication, combined with intensive therapy can improve social skills, language, and reduce anxiety in children with autism. Propranolol has been shown to improve cognitive performance, social skills, and conversation reciprocity in children with autism spectrum disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in General Social Outcome Measure (GSOM)
Change in Social Responsiveness Scale (SRS)
Secondary study objectives
Change in Aberrant Behavior Checklist (ABC)
Change in Autism Impact Measure (AIM)
Change in Preschool Anxiety Scale (PAS)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Propranolol armExperimental Treatment1 Intervention
Propranolol will be administered in the form of a liquid dose via oral syringe by the participants' parent/caregiver an hour before each EIBI session. To minimize risk, the bodyweight adjusted minimum dose of propranolol used safely for test anxiety in healthy adults (10mg) will be used: participants weighing \> 30 kg will be given 4 mg, participants weighing 22.5 - 30 kg will be given 3 mg, participants weighing 15 - 22.5 kg will be given 2 mg. Participants weighing \< 15 kg will be excluded for safety reasons.
Group II: Placebo armPlacebo Group1 Intervention
Placebo will be administered in the form of a liquid dose via oral syringe by the participants' parent/caregiver an hour before each EIBI session.The same bodyweight adjusted doses specified in the propranolol arm will be used for this arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol
2010
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
Autism Science FoundationOTHER
4 Previous Clinical Trials
183 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
183 Patients Enrolled for Autism Spectrum Disorder
University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,484 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
1,874 Patients Enrolled for Autism Spectrum Disorder
David Q Beversdorf, MDPrincipal InvestigatorUniversity of Missouri-Columbia
4 Previous Clinical Trials
103 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
79 Patients Enrolled for Autism Spectrum Disorder
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