An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome

Stopped early · Phase 2

Conditions studied: Fragile X Syndrome

In brief

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.

Key facts

Study ID

NCT01013480

Run by

Seaside Therapeutics, Inc.

People needed

45

Starts

2009-11-01

Expected to finish

2012-12-01

Last updated by the study team

2012-12-20

Who can join

Age: 6 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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