NCT05555615

Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Irritability Associated With Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Pimavanserin	Pimavanserin given once daily, as capsule of 10, 20, or 34 mg dose strength, respectively, according to the patient's age

Timeline

• Start date: 2022-11-02
• Primary completion: 2025-02-14
• Completion: 2025-02-14
• First posted: 2022-09-27
• Last updated: 2025-12-03
• Results posted: 2025-12-03

Locations

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

Regulatory

• FDA-regulated drug study