Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder

Part of paid clinical trials in Lawrence, Kansas.

Sponsor
New York State Psychiatric Institute
Study ID
NCT05999240
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID] — DRUG
    Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo at Visit 2.
  • Placebo — DRUG
    Placebo for Pimavanserin Tartrate 34 Mg ORAL CAPSILE \[NUPLAZID\]

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Pimavanserin tartrate
    Pimavanserin 34 mg white to off-white capsules.
  • Placebo Comparator: Placebo
    Placebo to Pimavanserin tartrate

Primary Outcome Measure

Evaluate the impact of a single dose of pimavanserin 34 mg versus placebo [ Time Frame: Post Intervention, 30 days after study completion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas, Center for ResearchLawrenceKansas66045
Anjali Pradeep, M.A
[email protected]
785-864-4461
Matt Mosconi, PhD (PRINCIPAL_INVESTIGATOR)
Ann Genovese, MD (SUB_INVESTIGATOR)
Robin Shafer, PhD (SUB_INVESTIGATOR)
Center for Autism and the Developing BrainWhite PlainsNew York10605
Alyssa Verdes, B.A.
[email protected]
914-997-5532
Suvekcha Bhattachan, M.A.
[email protected]
914-997-5587
Jeremy Veenstra-VanderWeele, MD (PRINCIPAL_INVESTIGATOR)
Pankhuree Vandana, MD (SUB_INVESTIGATOR)
Karen Tang, PhD (SUB_INVESTIGATOR)

Find similar trials in Lawrence, KS

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University of Kansas, Center for Research· Lawrence, KSCenter for Autism and the Developing Brain· White Plains, NY

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