Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
Public ClinicalTrials.gov record NCT04258839. 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 Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
Study identification
- NCT ID
- NCT04258839
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 95 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
- Jan 23, 2020 (Actual)
- Primary completion
- Mar 16, 2023 (Actual)
- Completion
- Mar 16, 2023 (Actual)
- Last update posted
- May 30, 2024
2020 – 2023
United States locations
- U.S. sites
- 28
- U.S. states
- 19
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dothan Behavioral Medicine Clinic | Dothan | Alabama | 36303 | — |
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | — |
| University of California San Francisco, Nancy Friend Pritzker Psychiatry | San Francisco | California | 94143-3132 | — |
| APG Research | Orlando | Florida | 32803 | — |
| Autism Assessment, Research, Treatment and Services (AARTS) center | Chicago | Illinois | 60612 | — |
| Research site | Lake Charles | Louisiana | 70629 | — |
| The Lurie Center for Autism | Lexington | Massachusetts | 02421-3114 | — |
| Research site | Bloomfield Hills | Michigan | 48302 | — |
| Thompson Center for Autism and Neurodevelopment | Columbia | Missouri | 65211 | — |
| Research site | Saint Charles | Missouri | 63304 | — |
| Alivation | Lincoln | Nebraska | 68526 | — |
| Center for Psychiatry and Behavioral Medicine Inc. | Las Vegas | Nevada | 89128 | — |
| Rutger's-New Jersey Medical Scholl Clinical Research Unit | Newark | New Jersey | 07103 | — |
| For additional information regarding sites | Princeton | New Jersey | 08540 | — |
| Bioscience Research | Mount Kisco | New York | 10549 | — |
| Research site | New York | New York | 10036 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| Research Site | Avon Lake | Ohio | 44012 | — |
| The Holloway Group, Inc | Oklahoma City | Oklahoma | 73116 | — |
| Access Clinical Trials | Nashville | Tennessee | 37203 | — |
| Research site | Austin | Texas | 78759 | — |
| Cedar Health Research | Dallas | Texas | 75251 | — |
| Research site | San Antonio | Texas | 78249 | — |
| UT Health San Antonio Long School of Medicine, Department of Psychiatry and Behavioral Sciences | San Antonio | Texas | 78289 | — |
| Family Psychiatry of the Woodlands | The Woodlands | Texas | 77381 | — |
| Woodstock Research Center | Woodstock | Vermont | 05091 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04258839, 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 May 30, 2024 · 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 NCT04258839 live on ClinicalTrials.gov.