Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

Summary

6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (aged 5 to17 years) with autism spectrum disorder (ASD) with irritability, agitation, or self-injurious behaviors to study the efficacy and safety of pimavanserin

Timeline

Start

2022-08-09

Primary completion

2024-09-27

Completion

2024-09-27

Publications

• Bugarski-Kirola D, Hofbauer RK, Sameljak S, Marco EJ, Sumila A, Darwish M, Ortiz S, Liu IY, Nunez R, Zhang PH, Arango C. Pimavanserin for Irritability in Children and Adolescents With Autism Spectrum Disorder: Phase 2 Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2026 May 19:S0890-8567(26)00229-7. doi: 10.1016/j.jaac.2026.05.007. Online ahead of print.

Drugs

Indications