A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
Public ClinicalTrials.gov record NCT03504917. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).
Study identification
- NCT ID
- NCT03504917
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 322 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 8, 2018 (Actual)
- Primary completion
- Mar 4, 2020 (Actual)
- Completion
- Jul 1, 2020 (Actual)
- Last update posted
- Oct 27, 2021
2018 – 2020
United States locations
- U.S. sites
- 32
- U.S. states
- 21
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | — |
| Southwest Autism Research & Resource Center | Phoenix | Arizona | 85006 | — |
| Woodland Research Northwest, LLC | Rogers | Arkansas | 72758 | — |
| University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry | Los Angeles | California | 90095 | — |
| PCSD Feighner Research | San Diego | California | 92108 | — |
| University of California at San Francisco | San Francisco | California | 94115 | — |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | — |
| Yale University / Yale-New Haven Hospital | New Haven | Connecticut | 06519-1124 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| APG- Advanced Psychiatric Group | Orlando | Florida | 32803 | — |
| IMIC Inc. | Palmetto Bay | Florida | 33157 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Uni of Chicago; Centre For Advanced Medicine | Chicago | Illinois | 60637 | — |
| Lake Charles Clinical Trials, LLC | Lake Charles | Louisiana | 70601 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | 55414 | — |
| Millennium Psychiatric Associates, LLC | St Louis | Missouri | 63132 | — |
| Hapworth Research Inc. | New York | New York | 10019 | — |
| Center for Autism and the Developing Brain | New York | New York | 10032 | — |
| Nathan S. Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| University Hospitals | Cleveland | Ohio | 44106 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| UPMC Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15203 | — |
| Vanderbilt University Medical Center; Department of Psychiatry | Nashville | Tennessee | 37212 | — |
| BioBehavioral Research of Austin, PC | Austin | Texas | 78759 | — |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | — |
| Aspen Clinical Research | Orem | Utah | 84058 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
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 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03504917, 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 Oct 27, 2021 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03504917 live on ClinicalTrials.gov.