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A randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome
A randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome
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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 (ages 16 to 50) 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.
(REF# Pro00039844)
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.
(REF# Pro00039844)
