A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
Public ClinicalTrials.gov record NCT01793441. 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 Multi-Center, Randomized, Double-Blind, 12-Week, Parallel Group, Placebo-Controlled Proof of Concept Study to Investigate the Efficacy and Safety of RG7314 in Individuals With Autism Spectrum Disorders (ASD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety review, the study may proceed to Stage II. In Stage II of the study, additional participants will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks. After an independent safety review, Stage III will be started wherein additional participants will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12 weeks. During Stage III, safety will be reviewed by independent safety review twice and if no safety signal is observed, then additional participants will be randomized in 1:1:1 either to receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in Stage IV.
Study identification
- NCT ID
- NCT01793441
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 223 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Male
- 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
- Sep 2013 (Type not available)
- Primary completion
- Sep 2016 (Actual)
- Completion
- Sep 2016 (Actual)
- Last update posted
- Feb 3, 2017
2013 – 2016
United States locations
- U.S. sites
- 56
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Autism Research & Resource Center | Phoenix | Arizona | 85006 | — |
| Not listed | Phoenix | Arizona | 85006 | — |
| University of California Davis | Sacramento | California | 95817 | — |
| Not listed | Sacramento | California | 95817 | — |
| PCSD Feighner Research | San Diego | California | 92108 | — |
| Not listed | San Diego | California | 92108 | — |
| University of California at San Francisco | San Francisco | California | 94115 | — |
| Not listed | San Francisco | California | 94115 | — |
| Not listed | Santa Ana | California | 92705 | — |
| Not listed | Stanford | California | 94305 | — |
| DBA IMMUNOe Int'l Res Center | Centennial | Colorado | 80112 | — |
| Not listed | Centennial | Colorado | 80112 | — |
| Yale University; Yale Child Study Center | New Haven | Connecticut | 06510 | — |
| Not listed | New Haven | Connecticut | 06510 | — |
| Neurology offices of south florida | Delray Beach | Florida | 33445 | — |
| Not listed | Delray Beach | Florida | 33445 | — |
| Research Centers of America, LLC | Oakland Park | Florida | 33334 | — |
| Not listed | Oakland Park | Florida | 33334 | — |
| Compass Research | Orlando | Florida | 32806 | — |
| Not listed | Orlando | Florida | 32806 | — |
| Emory University School of Medicine; Department of Human Genetics & Pediatrics | Decatur | Georgia | 30033 | — |
| Not listed | Decatur | Georgia | 30033 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| The Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Not listed | Baltimore | Maryland | 21205 | — |
| Neuroscientific Insights | Rockville | Maryland | 20852 | — |
| Not listed | Rockville | Maryland | 20852 | — |
| Massachusetts General Hospital | Lexington | Massachusetts | 02421 | — |
| Not listed | Lexington | Massachusetts | 02421 | — |
| University of Minnesota; Clin. Neuro Research Unit | Minneapolis | Minnesota | 55414 | — |
| Not listed | Minneapolis | Minnesota | 55414 | — |
| Mount Sinai School of Medicine; Seaver Autism Center | New York | New York | 10029 | — |
| Not listed | New York | New York | 10029 | — |
| Nathan S. Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | — |
| Not listed | Orangeburg | New York | 10962 | — |
| Montefiore Medical Center; Departments of Psychiatry & Biobehavioral Science | The Bronx | New York | 10467 | — |
| Not listed | The Bronx | New York | 10467 | — |
| DUKE SCHOOL OF MEDICINE;Duke Center for Autism and Brain Development | Durham | North Carolina | 27705 | — |
| Not listed | Durham | North Carolina | 27705 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Not listed | Cincinnati | Ohio | 45229 | — |
| University Hospitals | Cleveland | Ohio | 44106 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| UPMC Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15203 1101 | — |
| Not listed | Pittsburgh | Pennsylvania | 15203 1101 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Road Runner Research | San Antonio | Texas | 78258 | — |
| Not listed | San Antonio | Texas | 78258 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Not listed | Bellevue | Washington | 98007 | — |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | — |
| Not listed | Bothell | Washington | 98011 | — |
| Seattle Children's Research Institute | Seattle | Washington | 98145 | — |
| Not listed | Seattle | Washington | 98145 | — |
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 NCT01793441, 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 3, 2017 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01793441 live on ClinicalTrials.gov.