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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 <

Brief 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)

Detailed Summary:
Sponsor: Seaside Therapeutics, Inc.

Current Primary Outcome: Aberrant Behavior Checklist - FXS Social Avoidance Subscale [ Time Frame: At 8 weeks of treatment ]

Original Primary Outcome: Aberrant Behavior Checklist-Social Withdrawal Subscale [ Time Frame: At 8 weeks of treatment ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Seaside Therapeutics, Inc.

Dates:
Date Received: January 20, 2011
Date Started: May 2011
Date Completion:
Last Updated: July 30, 2013
Last Verified: July 2013