An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

Stopped early · Phase 2

Conditions studied: Autism Spectrum Disorders

In brief

Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 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 ASD who receive treatment under conditions more closely reflective of their general medical care.

Key facts

Study ID

NCT01064973

Run by

Seaside Therapeutics, Inc.

People needed

32

Starts

2010-02-01

Expected to finish

2012-12-01

Last updated by the study team

2012-12-20

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have completed all scheduled visits in protocol 22003 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 22003 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension

Where it is running

• Southwest Autism Research & Resource Center — Phoenix, Arizona, United States
• University of California-Los Angeles Neuropsychiatric Institute — Los Angeles, California, United States
• Yale Child Study Center — New Haven, Connecticut, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of North Carolina Neurosciences Hospital — Chapel Hill, North Carolina, United States
• Vanderbilt Kennedy Center — Nashville, Tennessee, United States
• Red Oaks Psychiatry Associates, P.A. — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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