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An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X Syndrome
Study 22001, "A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile X Syndrome" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with FXS. This study (22002) will enter subjects who complete Study 22001 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions more closely reflective of their general medical care.
Age
6 - 40 years
Sex
ALL
Healthy Volunteers
No
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States
M.I.N.D. Institute
Sacramento, California, United States
Rush University Medical Center
Chicago, Illinois, United States
NYS Institute for Basic Research in Developmental Disabilities
Staten Island, New York, United States
University of North Carolina Neurosciences Hospital
Chapel Hill, North Carolina, United States
Suburban Research Associates
Media, Pennsylvania, United States
Vanderbilt Kennedy Center
Nashville, Tennessee, United States
Red Oaks Psychiatry Associates, PA
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Start Date
November 1, 2009
Primary Completion Date
December 1, 2012
Completion Date
December 1, 2012
Last Updated
December 20, 2012
45
ACTUAL participants
Arbaclofen
DRUG
Lead Sponsor
Seaside Therapeutics, Inc.
NCT05418049
NCT07439510
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06261502