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Completed Phase 2Phase 3 Interventional Results available

Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

ClinicalTrials.gov ID: NCT05523895

Public ClinicalTrials.gov record NCT05523895. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 5, 2026, 3:08 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (aged 5 to17 years) with autism spectrum disorder (ASD) with irritability, agitation, or self-injurious behaviors to study the efficacy and safety of pimavanserin

Study identification

NCT ID
NCT05523895
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
ACADIA Pharmaceuticals Inc.
Industry
Enrollment
237 participants

Conditions and interventions

Eligibility (public fields only)

Age range
5 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 9, 2022 (Actual)
Primary completion
Sep 27, 2024 (Actual)
Completion
Sep 27, 2024 (Actual)
Last update posted
Aug 24, 2025

2022 – 2024

United States locations

U.S. sites
18
U.S. states
13
U.S. cities
18
Facility City State ZIP Site status
Southwest Autism Research & Resource Center Phoenix Arizona 85006 —
Cortica Inc. (Glendale) Glendale California 91361 —
Cortica Inc. (San Rafael) San Rafael California 94903 —
1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers Centennial Colorado 80112 —
Children's Research Institute Washington D.C. District of Columbia 20010 —
The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials Gainesville Florida 32607 —
APG Research, LLC Orlando Florida 32803 —
AMR Baber Research Incorporated Naperville Illinois 60563 —
Clinical Research of Southern Nevada, LLC Las Vegas Nevada 89128 —
ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates Staten Island New York 10314 —
Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC Avon Lake Ohio 44012 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19146 —
Medical University of South Carolina Charleston South Carolina 29425 —
Relaro Medical Trials, LLC Dallas Texas 75243 —
Red Oak Psychiatry Associates, PA Houston Texas 77090 —
AIM Trials, LLC Plano Texas 75093 —
Eastside Therapeutic Resource, Inc. dba Core Clinical Research Everett Washington 98201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05523895, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 24, 2025 · Synced Nov 5, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05523895 live on ClinicalTrials.gov.

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