Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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