Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Irritability Associated With Autism Spectrum Disorder
Age (in years)
5 - 18
Phase
Phase 2/Phase 3
Participants needed
228
Est. Completion Date
Jul 31, 2025
Treatment type
Interventional
Sponsor
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov identifier
NCT05555615
Study number
ACP-103-070
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