Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome
Public ClinicalTrials.gov record NCT01282268. 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 Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X Syndrome
Study identification
- NCT ID
- NCT01282268
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Seaside Therapeutics, Inc.
- Industry
- Enrollment
- 125 participants
Conditions and interventions
Conditions
Interventions
- arbaclofen Drug
- placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 50 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
- Apr 30, 2011
- Primary completion
- Nov 30, 2012
- Completion
- Not listed
- Last update posted
- Jul 30, 2013
Started 2011
United States locations
- U.S. sites
- 24
- U.S. states
- 18
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Autism Research & Resource Center | Phoenix | Arizona | 85006 | — |
| Miller Children's Hospital Research Administration | Long Beach | California | 90806 | — |
| University of California-Davis, M.I.N.D. Institute | Sacramento | California | 95817 | — |
| Psychiatric Centers at San Diego | San Diego | California | 92108 | — |
| University of Colorado Denver, Children's Hospital | Aurora | Colorado | 80045 | — |
| University of Miami, Mailman Center for Child Development | Miami | Florida | 33136 | — |
| Lake Mary Pediatrics | Orange City | Florida | 32763 | — |
| Emory University School of Medicine | Decatur | Georgia | 30033 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| University of Massachusetts | Worcester | Massachusetts | 01605 | — |
| University of Missouri, Thompson Research Center for Autism & Neurodevelpmental Disorders | Columbia | Missouri | 65211 | — |
| Seaver Autism Center, Mount Sinai Medical Center | New York | New York | 10029 | — |
| New York State Institute for Basic Research in Developmental Disabilities | Staten Island | New York | 10314 | — |
| Duke University Clinical Research Unit | Durham | North Carolina | 27005 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| University of Oklahoma, Physician's Child Study Center | Oklahoma City | Oklahoma | 73117 | — |
| Suburban Research Associates/Elwyn Genetics | Media | Pennsylvania | 19063 | — |
| Vanderbilt Kennedy Center | Nashville | Tennessee | 37203 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Red Oaks Psychiatry Associates, P.A. | Houston | Texas | 77090 | — |
| Road Runner Research | San Antonio | Texas | 78258 | — |
| Seattle Children's Hospital | Seattle | Washington | 98101 | — |
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 NCT01282268, 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 Jul 30, 2013 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01282268 live on ClinicalTrials.gov.