Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
NCT ID: NCT01325220
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
PHASE3
172 participants
INTERVENTIONAL
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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STX209 5 mg BID
arbaclofen
5 mg bid
STX209 10 mg BID
arbaclofen
10 mg bid
STX209 10 mg TID
arbaclofen
10 mg tid
Placebo
Placebo
tid
Interventions
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arbaclofen
5 mg bid
arbaclofen
10 mg bid
arbaclofen
10 mg tid
Placebo
tid
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
11 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
Miller Children's Hospital
Long Beach, California, United States
University of California-Davis, M.I.N.D. Institute
Sacramento, California, United States
Psychiatric Centers at San Diego
San Diego, California, United States
University of Colorado Denver, Children's Hospital
Aurora, Colorado, United States
University of Miami, Mailman Center for Child Development
Miami, Florida, United States
Lake Mary Pediatrics
Orange City, Florida, United States
Emory University School of Medicine
Decatur, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Kansas University Clinical Research Center
Fairway, Kansas, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
University of Massachusetts
Worcester, Massachusetts, United States
Children's Hospital of Michigan
Detriot, Michigan, 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
New York State Institute for Basic Research in Developmental Disabilities
Staten Island, New York, United States
Duke Clinical Research Unit
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
University of Oklahoma, Physician's Child Study Center
Oklahoma City, Oklahoma, United States
Suburban Research Associates/Elwyn Genetics
Media, Pennsylvania, United States
Greenwood Genetics Center
Greenwood, South Carolina, United States
Vanderbilt Kennedy Center
Nashville, Tennessee, United States
Childrens Medical Center Dallas
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, 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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209FX302
Identifier Type: -
Identifier Source: org_study_id