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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013480
Recruitment Status : Terminated (all active subjects rolled into 209FX303/NCT01013480)
First Posted : November 13, 2009
Last Update Posted : December 20, 2012
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.

November 12, 2009
November 13, 2009
December 20, 2012
November 2009
December 2012   (Final data collection date for primary outcome measure)
Irritability subscale of the Aberrant Behavior Checklist [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01013480 on Archive Site
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An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome
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.
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Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fragile X Syndrome
Drug: Arbaclofen
A flexible dose titration will be utilized during the first four weeks to define the optimal titrated dose (OTD) for each subject. Investigators will use clinical judgment to adjust doses to the OTD. The starting dose will be 1 mg BID. The dose may be increased every four to five days to 2 mg BID, 3 mg BID, 5 mg BID and then 10 mg BID
Other Names:
  • R-baclofen
  • STX209
Active Comparator: STX209
Intervention: Drug: Arbaclofen
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
6 Years to 40 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Seaside Therapeutics, Inc.
Seaside Therapeutics, Inc.
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Seaside Therapeutics, Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP