This Roche NP27936 study is a phase II, randomized, double-blind, 12-week, parallel-group study to evaluate the efficacy and safety of two fixed doses of RO4917523 compared to placebo in Adults and adolescents (14-17 years old) with FXS.
The main objectives of this study are:
• To evaluate the efficacy of 12-week treatment with RO4917523 in patients with FXS as measured by the Anxiety Depression and Mood Scale (ADAMS) social avoidance factor
• To evaluate the safety and tolerability of 12- week treatment with RO4917523 in patients with FXS.
The total duration of the study for each patient will be approximately 18 weeks which includes 7-8 study visits and 10 or more study phone calls.
Travel expenses will be reimbursed by the sponsor.
For more information, contact Wan Lan Liang (wan.liang@duke.edu) at (c) 919-328-0411, (o) 919-668-0972.
