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Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder

NCT05999240 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-01

No results posted yet for this study

Summary

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

Interventions

DRUG

Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]

Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo at Visit 2.

DRUG

Placebo

Placebo for Pimavanserin Tartrate 34 Mg ORAL CAPSILE \[NUPLAZID\]

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    collaborator INDUSTRY

  • University of Kansas Medical Center

    collaborator OTHER

  • Research Foundation for Mental Hygiene, Inc.

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Jeremy Veenstra-VanderWeele, MD · New York State Psychiatric Institute

  • Matthew Mosconi, PhD · University of Kansas Center for Autism Research and Training

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05999240 on ClinicalTrials.gov