Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ACADIA Pharmaceuticals Inc.
• Treatments: Pimavanserin

Criteria

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; stimulant and non-stimulant medications), 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.