Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

Stopped early · Phase 3

Conditions studied: Autism Spectrum Disorders

In brief

This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.

Key facts

Study ID

NCT01706523

Run by

Seaside Therapeutics, Inc.

People needed

165

Starts

2011-11-01

Expected to finish

2013-07-01

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…

• Subject completed study 22007 or 209AS208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study.
• Parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions.
• Treatment with no more than 2 psychoactive medications
• Subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol
• For female subjects, negative pregnancy test

You may not qualify if…

• Comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject.
• Current use of illicit drugs or alcohol abuse.
• Subjects with a serious adverse event or other adverse event in study 22007 or 209AS208 that was related to STX209, and that endangers the subject, in the opinion of the investigator
• Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole

Where it is running

• 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
• Southwest Autism Research & Resource Center — Phoenix, Arizona, United States
• University of California-Los Angeles Neuropsychiatric Institute — Los Angeles, California, United States
• UCDavis M.I.N.D Insitute — 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 & Neurodevelopmental Disorders — Columbia, Missouri, United States
• Seaver Autism Center, Mount Sinai Medical Center — New York, New York, United States
• NYS Institute for Basic Research in Developmental Disabilities — Staten Island, New York, United States
• UNC Chapel Hill Department of Psychiatry — Chapel Hill, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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