An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome
Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
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.