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

Completed · Phase 2

Conditions studied: Autism Spectrum Disorders

In brief

To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders

Key facts

Study ID

NCT01288716

Run by

Seaside Therapeutics, Inc.

People needed

150

Starts

2011-05-01

Expected to finish

2012-09-01

Last updated by the study team

2013-07-31

Who can join

Age: 5 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Autism Spectrum Disorders (ASD)
• Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
• Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
• If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening

You may not qualify if…

• Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
• Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
• Subjects who have taken another investigational drug within the last 30 days.
• Subjects who are not able to take oral medications

Where it is running

• Southwest Autism Research & Resource Center — Phoenix, Arizona, United States
• University of California-Los Angeles Neuropsychiatric Institute — Los Angeles, California, United States
• University of California-Davis, M.I.N.D. Institute — Sacramento, California, United States
• Pharmax Research Clinic — Miami, Florida, United States
• Lake Mary Pediatrics — Orange City, Florida, United States
• Institute for Behavioral Medicine — Smyrna, Georgia, United States
• Institute for Juvenile Research — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• University of Missouri, Thompson Research Center for Autism & Neurodevelpmental Disorders — Columbia, Missouri, United States
• Seaver Autism Center, Mount Sinai Medical Center — New York, New York, United States
• University of North Carolina Neurosciences Hospital — Chapel Hill, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Cutting Edge Research — Oklahoma City, Oklahoma, United States
• Summit Research Network — Portland, Oregon, United States
• Suburban Research Associates — Media, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Tennessee Medical Group, LeBonheur Children's Hospital — Memphis, Tennessee, United States
• Vanderbilt Kennedy Center — Nashville, Tennessee, United States
• Red Oaks Psychiatry Associates, P.A. — Houston, Texas, United States
• Road Runner Research — San Antonio, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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