Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders
NCT ID: NCT01288716
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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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2011-05-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
No interventions assigned to this group
Arbaclofen
Arbaclofen
Interventions
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Arbaclofen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
5 Years
21 Years
ALL
No
Sponsors
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Seaside Therapeutics, Inc.
INDUSTRY
Responsible Party
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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
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
Countries
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Other Identifiers
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209AS208
Identifier Type: -
Identifier Source: org_study_id