Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

Irritability Associated With Autism Spectrum Disorder Clinical Trial

Official title: A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)

Status Recruiting

Clinical Trial Summary

52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years).

ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).

Clinical Trial Description

This study will be conducted as a 52-week, open-label extension study of the antecedent double-blind study to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (5 through 17 years old at the time of enrolling into the antecedent double-blind study). ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Irritability Associated With Autism Spectrum Disorder

• NCT number: NCT05555615
• Study type: Interventional
• Source: ACADIA Pharmaceuticals Inc.
• Contact: Sharon Ortiz
• Phone: 646-397-7336
• Email: Sharon.Ortiz@acadia-pharm.com
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2, 2022
• Completion date: July 2025