Propranolol for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
Severe challenging behaviors such as aggression and self-injury can cause significant morbidity and decrease the quality of life for individuals with Autism Spectrum Disorders (ASD). There are only two medications (Risperdal and Abilify) rigorously studied and FDA-approved for the treatment of irritability in individuals with ASD. These medications are not always successful and have many short and long-term side effects. Well-designed studies demonstrating efficacy and safety of alternative medication treatment choices are needed. There is preliminary evidence that high-dose propranolol can be effective in individuals with ASD who display severe aggression and have not responded to antipsychotics or mood stabilizers. Concerns regarding the safety of high dose propranolol have limited its clinical application. Well-designed clinical trials demonstrating the efficacy and safety of high dose propranolol will have significant effects on clinical practice and improve the physical and behavioral quality of life for an underserved subset of individuals with ASD.This study will pilot the safety and efficacy of high dose propranolol. The investigators will randomly assign participants to either propranolol or to placebo later crossing each participant over to the other group. As propranolol can cause changes in blood pressure and heart function, each participant will complete initial comprehensive testing to monitor cardiac safety throughout the study. The investigators will be utilizing telemedicine and computer based telemetry to minimize the burden of office visits on the individual and family.
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Cognitive and adaptive information is collected before randomization
Treatment Phase A
Participants receive either Propranolol or Placebo with weekly monitoring
Washout
Participants undergo a washout period before crossover
Treatment Phase B
Participants crossover to receive the alternate treatment (Propranolol or Placebo)
Open-label Extension
Participants continue in an open-label phase with Propranolol
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Propranolol
Propranolol is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
New Jersey Governor's Council for Medical Research and Treatment of Autism
Collaborator
New York State Institute for Basic Research
Collaborator