NCT01325220

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

A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Seaside Therapeutics, Inc. · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	arbaclofen	5 mg bid
DRUG	arbaclofen	10 mg bid
DRUG	arbaclofen	10 mg tid
DRUG	Placebo	tid

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-06-01
• First posted: 2011-03-29
• Last updated: 2013-07-31

Locations

28 sites across 1 country: United States