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Completed Phase 2 Interventional

Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

ClinicalTrials.gov ID: NCT01288716

Public ClinicalTrials.gov record NCT01288716. 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 Jul 22, 2026, 4:12 PM 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 Withdrawal in Subjects With Autism Spectrum Disorders

Study identification

NCT ID
NCT01288716
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Enrollment
150 participants

Conditions and interventions

Interventions

  • Arbaclofen Drug

Drug

Eligibility (public fields only)

Age range
5 Years to 21 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
Jul 31, 2012
Completion
Aug 31, 2012
Last update posted
Jul 30, 2013

2011 – 2012

United States locations

U.S. sites
24
U.S. states
18
U.S. cities
24
Facility City State ZIP Site status
Southwest Autism Research & Resource Center Phoenix Arizona 85006
University of California-Los Angeles Neuropsychiatric Institute Los Angeles California 90024
University of California-Davis, M.I.N.D. Institute Sacramento California 95817
Pharmax Research Clinic Miami Florida 33126
Lake Mary Pediatrics Orange City Florida 32763
Institute for Behavioral Medicine Smyrna Georgia 30080
Institute for Juvenile Research Chicago Illinois 60608
Riley Hospital for Children Indianapolis Indiana 46202
Kennedy Krieger Institute Baltimore Maryland 21205
Boston Children's Hospital Boston Massachusetts 02115
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
University of North Carolina Neurosciences Hospital Chapel Hill North Carolina 27514
Akron Children's Hospital Akron Ohio 44308
Cutting Edge Research Oklahoma City Oklahoma 73116
Summit Research Network Portland Oregon 97210
Suburban Research Associates Media Pennsylvania 19063
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
University of Tennessee Medical Group, LeBonheur Children's Hospital Memphis Tennessee 38103
Vanderbilt Kennedy Center Nashville Tennessee 37203
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 NCT01288716, 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 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01288716 live on ClinicalTrials.gov.

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