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Completed Phase 3 Interventional

Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome

ClinicalTrials.gov ID: NCT01282268

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.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:06 AM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)

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

Interventions

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
May 2011 (Type not available)
Primary completion
Dec 2012 (Actual)
Completion
Not listed
Last update posted
Jul 31, 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 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 NCT01282268 live on ClinicalTrials.gov.

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