An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome
- Registration Number
- NCT01013480
- Lead Sponsor
- Seaside Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
- Have completed all scheduled visits in protocol 22001 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator
- Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
- The occurrence or continuation of any adverse event or condition during study 22001 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description STX209 Arbaclofen -
- Primary Outcome Measures
Name Time Method Irritability subscale of the Aberrant Behavior Checklist 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University of California-Los Angeles Neuropsychiatric Institute
🇺🇸Los Angeles, California, United States
M.I.N.D. Institute
🇺🇸Sacramento, California, United States
Red Oaks Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, 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
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Vanderbilt Kennedy Center
🇺🇸Nashville, Tennessee, United States