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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01013480
Other study ID # 22002
Secondary ID
Status Terminated
Phase Phase 2
First received November 12, 2009
Last updated December 19, 2012
Start date November 2009
Est. completion date December 2012

Study information

Verified date March 2011
Source Seaside Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 45
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 40 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of North Carolina Neurosciences Hospital Chapel Hill North Carolina
United States Rush University Medical Center Chicago Illinois
United States Red Oaks Psychiatry Associates, PA Houston Texas
United States University of California-Los Angeles Neuropsychiatric Institute Los Angeles California
United States Suburban Research Associates Media Pennsylvania
United States Vanderbilt Kennedy Center Nashville Tennessee
United States M.I.N.D. Institute Sacramento California
United States Seattle Children's Hospital Seattle Washington
United States NYS Institute for Basic Research in Developmental Disabilities Staten Island New York

Sponsors (1)

Lead Sponsor Collaborator
Seaside Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Irritability subscale of the Aberrant Behavior Checklist 1 year No
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