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

Seaside Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Fragile X Syndrome

Treatments

Drug: Arbaclofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT01013480

22002

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

6 to 40 years old

Volunteers

No Healthy Volunteers

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.