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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X Syndrome

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 Summary:
Sponsor: Seaside Therapeutics, Inc.

Current Primary Outcome: Irritability subscale of the Aberrant Behavior Checklist [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Seaside Therapeutics, Inc.

Dates:
Date Received: November 12, 2009
Date Started: November 2009
Date Completion:
Last Updated: December 19, 2012
Last Verified: March 2011