Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
Public ClinicalTrials.gov record NCT01325220. 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, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily \[BID\], 10 mg BID or 10 mg three times daily \[TID\]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically
Study identification
- NCT ID
- NCT01325220
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 172 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 11 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
- Jun 2011 (Type not available)
- Primary completion
- Jun 2013 (Actual)
- Completion
- Not listed
- Last update posted
- Jul 31, 2013
Started 2011
United States locations
- U.S. sites
- 28
- U.S. states
- 20
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southwest Autism Research & Resource Center | Phoenix | Arizona | 85006 | — |
| Miller Children's Hospital | 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 | — |
| Kansas University Clinical Research Center | Fairway | Kansas | 66205 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| University of Massachusetts | Worcester | Massachusetts | 01605 | — |
| Children's Hospital of Michigan | Detriot | Michigan | 48201 | — |
| University of Missouri, Thompson Research Center for Autism & Neurodevelopmental 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 Clinical Research Unit | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| University of Oklahoma, Physician's Child Study Center | Oklahoma City | Oklahoma | 73117 | — |
| Suburban Research Associates/Elwyn Genetics | Media | Pennsylvania | 19063 | — |
| Greenwood Genetics Center | Greenwood | South Carolina | 29646 | — |
| Vanderbilt Kennedy Center | Nashville | Tennessee | 37203 | — |
| Childrens Medical Center Dallas | Dallas | Texas | 75235 | — |
| 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 NCT01325220, 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 31, 2013 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01325220 live on ClinicalTrials.gov.