Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
Public ClinicalTrials.gov record NCT05555615. 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.
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Official title
A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years). ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).
Study identification
- NCT ID
- NCT05555615
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 209 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 5 Years to 18 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
- Nov 2, 2022 (Actual)
- Primary completion
- Feb 14, 2025 (Actual)
- Completion
- Feb 14, 2025 (Actual)
- Last update posted
- Dec 3, 2025
2022 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | — |
| Cortica Inc. (Glendale) | Glendale | California | 91361 | — |
| Cortica Inc. | 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 | 32803-3809 | — |
| 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 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05555615, 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 Dec 3, 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 NCT05555615 live on ClinicalTrials.gov.