Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

Stopped early · Phase 2/Phase 3

Conditions studied: Irritability Associated With Autism Spectrum Disorder

In brief

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).

Key facts

Study ID

NCT05555615

Run by

ACADIA Pharmaceuticals Inc.

People needed

209

Starts

2022-11-02

Expected to finish

2025-02-14

Last updated by the study team

2025-12-03

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Where it is running

• 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
• Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC — Avon Lake, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Relaro Medical Trials, LLC — Dallas, Texas, United States
• Red Oak Psychiatry Associates, PA — Houston, Texas, United States
• AIM Trials, LLC — Plano, Texas, United States
• Eastside Therapeutic Resource, Inc. dba Core Clinical Research — Everett, Washington, United States
• Children's Health Queensland Hospital and Health Service — South Brisbane, Queensland, Australia
• Monash Health — Clayton, Victoria, Australia
• Murdoch Children's Research Institute — Parkville, Victoria, Australia
• Centre Hospitalier Charles Perrens — Bordeaux, France
• Centre de Ressources Autisme Rhône-Alpes - Center Hospitalier le Vinatier — Bron, France
• CHU de Nantes — Nantes, France
• L'Assistance Publique - Hôpitaux de Paris, labélisé Institut Carnot — Paris, France

Full record on ClinicalTrials.gov

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