Actively Recruiting
Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder
Led by New York State Psychiatric Institute · Updated on 2026-04-01
30
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
Sponsors
N
New York State Psychiatric Institute
Lead Sponsor
A
ACADIA Pharmaceuticals Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This Phase 2 study examines the safety, tolerability, and preliminary efficacy of pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged 12 to 40 years of age will be randomized to receive single doses of either placebo or pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by open label extension.
CONDITIONS
Official Title
Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be between 12 and 40 years old
- Participant or legal representative must be able and willing to sign informed consent
- Participants under 18 must have parent or guardian consent and assent as appropriate
- Must have Autism Spectrum Disorder diagnosis per DSM-5 and supported by ADOS-2
- Must have a Clinical Global Impression Severity score for repetitive behavior of 4 or greater
- Must have a non-verbal IQ of 70 or higher
- Must be able to speak and understand English
- Must live with a parent, caregiver, or adult informant who spends at least 4 hours daily with participant
- Informant must speak and understand English
- Must be able to self-administer or have caregiver administer study medication
- Must be able to swallow medication whole with liquid
- Must be willing to continue current medications and behavioral interventions without changes during the study
You will not qualify if you...
- Unable to comply with study requirements
- Investigator or family member of investigator involved in study
- History of severe or unstable psychiatric conditions that may interfere with study
- Recent or current significant suicidal ideation or behavior
- Substance abuse disorder within last 6 months (except caffeine or nicotine)
- Positive test for illicit drugs or cannabis (unless abstinent with prescription)
- Taking serotonin reuptake inhibitors or antipsychotic medications
- Recent changes to psychotropic medications within 2 months
- Electroconvulsive therapy within last 6 months
- New or changed psychotherapy within 2 months prior to screening
- Allergies or intolerance to pimavanserin or its ingredients
- Participation in other investigational drug or device studies within 3 months
- Body mass index under 17 or over 40
- History or family history of serious heart conditions or sudden death
- Recent serious cardiovascular events or unstable heart disease
- History of neuroleptic malignant syndrome or serotonin syndrome
- Seizure within past 12 months (stable seizure disorders allowed at discretion)
- Pregnant, breastfeeding, or planning pregnancy during study or within 3 months after
- Serious unstable medical disorders that may risk safety
- History of malignancy within 5 years except certain skin or cervical cancers
- Positive hepatitis C or HIV test
- Abnormal ECG findings related to QT interval
- Laboratory hypothyroidism unless compensated
- Unstable diabetes or HbA1c over 8%
- Other clinically significant lab abnormalities that would risk safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Kansas, Center for Research
Lawrence, Kansas, United States, 66045
Actively Recruiting
2
Center for Autism and the Developing Brain
White Plains, New York, United States, 10605
Actively Recruiting
Research Team
A
Alyssa Verdes, BA
CONTACT
S
Suvekcha Bhattachan, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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