NCT00823368|CompletedDMC
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Sponsor study identifier
observational
N/A
1 country
11
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
Not reported
Date not reportedThe subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 13, 2009
Actual (reported)January 15, 2009
Actual (reported)March 2010
Actual (reported)change in plasma proteins with treatment
After 4 weeks of treatment
Fragile x syndrome subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
Contact the study team to confirm eligibility.
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006, United States
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, 90024, United States
M.I.N.D. Institute
Sacramento, California, 95817, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
NYS Institute for Basic Research in Developmental Disabilities
Staten Island, New York, 10314, United States
University of North Carolina Neurosciences Hospital
DNA from blood,plasma
Elizabeth Berry-Kravis, MD, PhD
Rush University Medical Center
Randi Hagerman, MD
M.I.N.D. Institute
Craig Erikson, MD
Riley Hospital for Children
Bryan King, MD, PhD
Seattle Children's Hospital
First Submitted
January 13, 2009
First Posted
January 15, 2009
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
Chapel Hill, North Carolina, 27514, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Vanderbilt Kennedy Center
Nashville, Tennessee, 37203, United States
Red Oaks Psychiatry Associates, PA
Houston, Texas, 77090, United States
Seattle Children's Hospital
Seattle, Washington, 98101, United States
James McCracken, MD
University of California, Los Angeles
Jonathan Picker, MBChB, PhD
Boston Children's Hospital
Linmarie Sikich, MD
University of North Carolina Neurosciences Hospital
Jeremy Veenstra-VanderWeele, MD
Vanderbilt Kennedy Center
Ted Brown, MD, PhD
NYS Institute for Basic Research in Developmental Disabilities
Lawrence Ginsberg, MD
Red Oaks Psychiatry Associates, PA
Shivkumar Hatti, MD
Suburban Research Associates
Raun Melmed, MD
Southwest Autism Research & Resource Center
Last Updated
July 31, 2013
Record last verified: 2013-07
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