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Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

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)

NCT05555615•ACADIA Pharmaceuticals Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

5 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has completed the treatment period of study ACP-103-069
•Informed consent prior to the conduct of any study procedures
•Continues to be both clinically stable and not at imminent risk of suicide or injury to self, others, or property
•Continues to be medically stable at enrollment
•For female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. Females of childbearing potential must have a negative pregnancy test

Exclusion Criteria

•Patient or parent/legally accepted representative is judged by the Investigator to be inappropriate for the study
•Requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate), medications that prolong the QT interval; and strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
•At a significant risk of suicide, or is a danger to self or others
•At risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others
•Positive urine drug test
•Serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies
•Any change in medical or treatment status that may increase the risk associated with taking pimavanserin, would interfere with safety assessments, or would confound the interpretation of study results
•Clinically significant abnormal ECG of protocol-defined cardiac conduction abnormalities
•Weight \<15 kg

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 D.C., 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

Key Dates

Start Date

November 2, 2022

Primary Completion Date

February 14, 2025

Completion Date

February 14, 2025

Last Updated

December 3, 2025

Enrollment

209

ACTUAL participants

Conditions

Irritability Associated With Autism Spectrum Disorder

Interventions

Pimavanserin

DRUG

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

NCT04258839

Irritability Associated With Autism Spectrum Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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