Pimavanserin for the Treatment of Irritability Associated With ASD

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The purpose of this study is to test an investigational medication in children and adolescents aged 5-17 years old with irritability associated with autism spectrum disorder (ASD). The name of the medication being tested in this study is pimavanserin. This medication is investigational because it has not been approved by the FDA for the treatment of irritability associated with autism. The main risks of this study are from the medication, which include nausea, dizziness, and sleepiness.
If you are eligible and agree to participate, you will be randomly assigned to receive either placebo (a pill with no medication in it) or the study medication. Participation will last approximately 15 weeks and involve 8 study visits and one phone call. You will need to take the study drug for 6 weeks.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at Wozniaks1 [at] chop.edu or 267-600-5025.

Eligibility & Criteria

IRB #:
22-019780
Official Title:
A Phase 2, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
Study Phase:
Phase II
Eligible Age Range:
5 - 17 Years
Gender:
All
Study Categories:

Visit Criteria

Participants will take the study medication or a placebo (a pill without medication in it) and visit CHOP Philadelphia Campus 8 times over the course of 15 weeks.  During these visits participants will get blood, urine and heart monitoring tests, and complete behavioral assessments and questionnaires.
At the end of this study, participants may have the opportunity to participate in an extension study looking at how well the study medication works over 52 weeks.
Study participants receive the study drug at no cost. Compensation will be provided to offset the costs of travel. You do not need to be a patient at CHOP to participate.