NCT01282268

Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Seaside Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	arbaclofen	orally disintegrating tablet
DRUG	placebo	orally disintegrating tablet

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-12-01
• First posted: 2011-01-24
• Last updated: 2013-07-31

Locations

24 sites across 1 country: United States