Pimavanserin for Autism Spectrum Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing pimavanserin, a medication that may help reduce irritability, agitation, and self-harm in young individuals with autism. The study focuses on those who struggle with these challenging behaviors. Pimavanserin works by balancing brain chemicals to improve mood and behavior.
Will I have to stop taking my current medications?
The trial requires stopping certain medications, including those that target irritability, medications that affect heart rhythm, and certain enzyme inhibitors and inducers. If you're on these, you may need to stop them before joining the trial.
How is the drug Pimavanserin unique for treating Autism Spectrum Disorder?
Pimavanserin is unique because it is a selective serotonin 2A receptor inverse agonist, originally approved for treating hallucinations and delusions in Parkinson's disease psychosis, and it may offer a novel approach for Autism Spectrum Disorder by targeting serotonin pathways differently than other treatments.12345
Are You a Good Fit for This Trial?
This trial is for children and adolescents aged 5 to 17 with Autism Spectrum Disorder (ASD) who show irritability, agitation, or self-injurious behaviors. They must be able to swallow pills, have not used antipsychotic drugs before or had issues with them, and meet specific criteria for ASD diagnosis. Girls must use non-hormonal contraception if of childbearing age.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pimavanserin or placebo for 6 weeks to evaluate efficacy and safety for irritability associated with ASD
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pimavanserin
- Placebo
Pimavanserin is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
ACADIA Pharmaceuticals Inc.
Lead Sponsor