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Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Dec 31, 2026 → Oct 31, 2027
See other at-risk trials from New York State Psychiatric Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Oct 31, 2027
    • Study completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Collaborators reordered
    v19
  2. Eligibility criteria expanded, about 53 words
    • Study sites revised (2)
    v18
  3. Primary and study completion dates: May 15, 2026 to Dec 31, 2026v17
  4. Site details revised at 1 of 2 sitesv16
  5. Start date: Apr 28, 2025 to Oct 1, 2025v15
Show 13 earlier versionsHide 13 earlier versions
  1. Site contacts updated at 1 of 2 sitesv14
  2. Start date changed from estimate of Apr 15, 2025 to Apr 28, 2025
    • Site contacts updated at 2 of 2 sites
    v13
  3. Start date: Mar 1, 2025 to Apr 15, 2025v12
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 15, 2025 to Mar 1, 2025
    • Site details revised at 2 of 2 sites
    v11
  5. Start date: Jan 15, 2025 to Feb 15, 2025
    • Primary and study completion dates: Apr 15, 2026 to May 15, 2026
    v10
  6. Start date: Nov 15, 2024 to Jan 15, 2025
    • Primary and study completion dates: Feb 15, 2026 to Apr 15, 2026
    v9
  7. Start date: Sep 15, 2024 to Nov 15, 2024
    • Primary completion date: Dec 15, 2025 to Feb 15, 2026
    • Site contacts updated at 2 of 2 sites
    v8
  8. Start date: Jul 25, 2024 to Sep 15, 2024v7
  9. Start date: May 1, 2024 to Jul 25, 2024
    • Primary completion date: Oct 15, 2025 to Dec 15, 2025
    • Study completion date: Dec 15, 2025 to Feb 15, 2026
    v6
  10. Start date: Mar 1, 2024 to May 1, 2024v5
  11. Start date: Dec 1, 2023 to Mar 1, 2024v4
  12. Start date: Oct 15, 2023 to Dec 1, 2023v3
  13. Start date: Aug 15, 2023 to Oct 15, 2023
    • Primary completion date: Aug 15, 2025 to Oct 15, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05999240
Lead Sponsor New York State Psychiatric Institute
Collaborators: University of Kansas Medical Center, Research Foundation for Mental Hygiene, Inc., Weill Medical College of Cornell University, ACADIA Pharmaceuticals Inc.
Conditions
(from sponsor)		 Autism Spectrum Disorder
Related terms Autism Spectrum Disorder, Autistic Disorder
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov