Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder

Status Not yet recruiting

Clinical Trial Summary

This Phase 2 study examines the safety, tolerability, and preliminary efficacy of pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged 16 to 40 years of age will be randomized to receive single doses of either placebo or pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by open label extension.

Clinical Trial Description

The goal of this clinical trial is to learn the safety, tolerability and to assess pimavanserin for effects on behavioral rigidity and rigid-compulsive behavior in adolescents and adults with Autism Spectrum Disorder. Participants who meet protocol criteria will be randomly assigned to receive either pimavanserin or placebo in a 1:1 ratio in the Treatment Period. After completing the second experimental day of the cross-over trial, participants will immediately enter the Open-Label Trial, where they will take pimavanserin 34 mg for six weeks total. There will be 2 recruiting sites with a total sample of 30 participants. Blinding will be maintained by using identical tablets containing either Pimavanserin or placebo. ;

Study Design

Related Conditions & MeSH terms

Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive

Clinical Trial Details

NCT number	NCT05999240
Study type	Interventional
Source	New York State Psychiatric Institute
Contact	Alyssa Verdes, BA
Phone	914-997-5532
Email	alyssa.verdes@nyspi.columbia.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	July 25, 2024
Completion date	February 15, 2026

View Details

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