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

Phase 2TerminatedNCT01013480

Seaside Therapeutics, Inc.45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fragile X Syndrome

Interventions

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (9)

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