Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

Phase 2

Terminated

• Conditions: Irritability Associated With Autism Spectrum Disorder
• Interventions: Drug: Pimavanserin

• Registration Number: NCT05555615
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

Brief 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).

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Study Start: 2022-11-02
• Primary Completion: 2025-02-14
• Study Completion: 2025-02-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pimavanserin	Pimavanserin	Pimavanserin once daily. All patients will receive the pimavanserin low dose (patients aged 5 to 12 years: 10 mg/day pimavanserin; patients aged 13 to 17 years: 20 mg/day) the first 2 weeks of the study. Thereafter, the dose may be increased to the high dose (5 to 12 years: 20 mg/day; 13 to 17 years: 34 mg/day) based on the Investigator's assessment of clinical response. After Week 2 and up to Week 20, dose adjustments are allowed at any clinic visit based on the Investigator's assessment of clinical response and tolerability. No further dose adjustments are allowed after Week 20.

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events	52 weeks	Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.

Secondary Outcome Measures

Name	Time	Method
Evaluate the continued response to long-term pimavanserin treatment in children and adolescents with irritability associated with ASD, defined by a composite endpoint of ABC-I and CGI-I response.	52 weeks	Evaluate the continued response to long-term pimavanserin treatment in children and adolescents with irritability associated with ASD as assessed by a composite of a reduction in the Aberrant Behavior Checklist-Irritability (ABC-I) subscale score from baseline combined with a reduction in Clinical Global Impression-Improvement (CGI-I) of irritability score from baseline.

Trial Locations

Locations (48)

Southwest Autism Research and Resource Center; 🇺🇸 Phoenix, Arizona, United States

Cortica Inc. (Glendale); 🇺🇸 Glendale, California, United States

Cortica Inc.; 🇺🇸 San Rafael, California, United States

1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers; 🇺🇸 Centennial, Colorado, United States

Children's Research Institute; 🇺🇸 Washington, District of Columbia, United States

The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States

APG Research, LLC; 🇺🇸 Orlando, Florida, United States

AMR Baber Research Incorporated; 🇺🇸 Naperville, Illinois, United States

Clinical Research of Southern Nevada, LLC; 🇺🇸 Las Vegas, Nevada, United States

ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates; 🇺🇸 Staten Island, New York, United States

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