Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

Summary

There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily \[BID\], 10 mg BID or 10 mg three times daily \[TID\]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically

Timeline

Start

2011-06

Primary completion

2013-06

Completion

—

Drugs

Indications