Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
Reason given: The study was terminated for business reasons and not due to safety concerns.
Key facts
- Where
- Avon Lake, Centennial, Charleston, Cincinnati, Dallas, Everett, Gainesville, Glendale, Houston, Las Vegas, Naperville, Orlando, Philadelphia, Phoenix, Plano, San Rafael, Staten Island, and Washington D.C., United StatesSee the 18 sites
- Phase
- Phase 2/3
Where in United States
- Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLCAvon Lake, United StatesNo longer taking part
- 1st Allergy and Clinical Research Group, d/b/a IMUNOe Research CentersCentennial, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesNo longer taking part
- Relaro Medical Trials, LLCDallas, United StatesNo longer taking part
- Eastside Therapeutic Resource, Inc. dba Core Clinical ResearchEverett, United StatesNo longer taking part
- The EHS Medical Practice, PA, D/B/A Sarkis Clinical TrialsGainesville, United StatesNo longer taking part
- Cortica Inc. (Glendale)Glendale, United StatesNo longer taking part
- Red Oak Psychiatry Associates, PAHouston, United StatesNo longer taking part
- Clinical Research of Southern Nevada, LLCLas Vegas, United StatesNo longer taking part
- AMR Baber Research IncorporatedNaperville, United StatesNo longer taking part
- APG Research, LLCOrlando, United StatesNo longer taking part
- The Children's Hospital Of PhiladelphiaPhiladelphia, United StatesNo longer taking part
- Southwest Autism Research and Resource CenterPhoenix, United StatesNo longer taking part
- Aim Trials, LLCPlano, United StatesNo longer taking part
- Cortica Inc.San Rafael, United StatesNo longer taking part
- ERG Clinical Research - New York, PLLC DBA Richmond Behavioral AssociatesStaten Island, United StatesNo longer taking part
- Children's Research InstituteWashington D.C., United StatesNo longer taking part
Trial details
- Who runs it
- ACADIA Pharmaceuticals Inc.
- Trial code
- NCT05555615
- Record updated
- 3 December 2025
- Original description
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).Read full original descriptionShow less
A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)
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).
Inclusion: 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: Positive urine drug test; Serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies; Clinically significant abnormal ECG of protocol-defined cardiac conduction abnormalities; 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; Patient or parent/legally accepted representative is judged by the Investigator to be inappropriate for the study; 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; 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; Weight <15 kg; Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.