NCT05523895

Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study will be conducted as a 6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (5 through 17 years of age) with ASD with irritability, agitation, or self-injurious behaviors.

Conditions

• Irritability Associated With Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Pimavanserin	Pimavanserin
DRUG	Placebo	Pimavanserin matching placebo

Timeline

• Start date: 2022-08-09
• Primary completion: 2024-09-27
• Completion: 2024-09-27
• First posted: 2022-08-31
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

57 sites across 8 countries: United States, Australia, France, Hungary, Italy, Poland, Serbia, Spain

Regulatory

• FDA-regulated drug study