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

ACP-103-070

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).

2022-11-02

2025-07-01

2025-07-01

Recruiting

Early phase I

228

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 228, 'type': 'ESTIMATED'}}

2024-06-10