A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)
Public ClinicalTrials.gov record NCT02901431. 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 II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
For participants enrolled prior to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of balovaptan in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient \[IQ\] greater than or equal to \[\>=\] 70). For participants enrolled according to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, parallel group, placebo-controlled, 2-arm study with participants assigned either to a 10 milligram (mg) or equivalent dose of balovaptan, or placebo. All other study parameters remained as stated above. There are three parts to this study: PK Part (Study part 1) included up to 8 weeks of treatment, Main Treatment Part (Study part 2) included 24 week of treatment, and the Open Label Extension Part (Study part 3) included Week 24 to Week 76 of treatment. All participants that completed the 24-week treatment period were eligible to participate in an optional 52-week open-label extension (OLE) during which they received balovaptan treatment.
Study identification
- NCT ID
- NCT02901431
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 339 participants
Conditions and interventions
Conditions
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
- Nov 21, 2016 (Actual)
- Primary completion
- Apr 15, 2020 (Actual)
- Completion
- Jun 30, 2020 (Actual)
- Last update posted
- Feb 8, 2021
2016 – 2020
United States locations
- U.S. sites
- 45
- U.S. states
- 20
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | — |
| Southwest Autism Research & Resource Center | Phoenix | Arizona | 85006 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| PCSD Feighner Research | San Diego | California | 92108 | — |
| University of California at San Francisco | San Francisco | California | 94115 | — |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | — |
| DBA IMMUNOe Int'l Res Center | Centennial | Colorado | 80112 | — |
| Yale University / Yale-New Haven Hospital | New Haven | Connecticut | 06519-1124 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Segal trials | North Miami | Florida | 33161 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| APG- Advanced Psychiatric Group | Orlando | Florida | 32803 | — |
| USF Rothman Center | St. Petersburg | Florida | 33701 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | — |
| Massachusetts General Hospital; Lurie Center for Autism | Lexington | Massachusetts | 02421 | — |
| UMASS Medical School | Worcester | Massachusetts | 01655 | — |
| University of Minnesota; Clin. Neuro Research Unit | Minneapolis | Minnesota | 55414 | — |
| St. Charles Psychiatric Associates | Saint Charles | Missouri | 63304 | — |
| Midwest Childrens Health Research Institute | Lincoln | Nebraska | 68516 | — |
| Center for Autism and the Developing Brain | New York | New York | 10032 | — |
| Nathan S. Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | — |
| University of Rochester | Rochester | New York | 14627 0001 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| DUKE SCHOOL OF MEDICINE;Duke Center for Autism and Brain Development | Durham | North Carolina | 27705 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University Hospitals | Cleveland | Ohio | 44106 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Children's Hospital of Philadelphia;Allergy/Immunology Department | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| BioBehavioral Research of Austin, PC | Austin | Texas | 78759 | — |
| Relaro Medical Trials | Dallas | Texas | 75243 | — |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | — |
| Road Runner Research | San Antonio | Texas | 78249 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
| Seattle Children's Research Institute; Psychiatry and Behavioral Medicine | Seattle | Washington | 98121 | — |
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 NCT02901431, 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 Feb 8, 2021 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02901431 live on ClinicalTrials.gov.