Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
NCT ID: NCT01706523
Last Updated: 2013-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
165 participants
INTERVENTIONAL
2011-11-30
2013-07-31
Brief Summary
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Detailed Description
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Protocol 209AS208, "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."
Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."
This open-label extension will provide data on the following:
1. Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
2. Provide supporting pharmacokinetic analyses
3. Assess long term efficacy on social behaviors in subjects with ASD.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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STX209
Active treatment with STX209
STX209 (arbaclofen)
Long-term, daily, orally-administered STX209
Interventions
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STX209 (arbaclofen)
Long-term, daily, orally-administered STX209
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
5 Years
21 Years
ALL
No
Sponsors
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Seaside Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Wang, M.D.
Role: STUDY_DIRECTOR
Seaside Therapeutics, Inc.
Locations
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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
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
Countries
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Other Identifiers
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209AS209
Identifier Type: -
Identifier Source: org_study_id