Clinical Trial: Study of Acamprosate in Fragile x Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Double-Blind, Placebo-Controlled Proof of Concept Study in Youth With Fragile X Syndrome
Brief Summary: In this research study we want to understand the effectiveness of a drug treatment, acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment) associated with Fragile X Syndrome (FXS).
Detailed Summary:
Sponsor: Children's Hospital Medical Center, Cincinnati
Current Primary Outcome: Aberrant Behavior Checklist-Social Withdrawal subscale [ Time Frame: Change from baseline to week 10 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical Global Impressions- Improvement (CGI-I) [ Time Frame: week 10 ]
- Aberrant Behavior Checklist- Hyperactivity (ABC-H) [ Time Frame: Change from baseline to week 10 ]
- Aberrant Behavior Checklist-Social Avoidance (ABC-SA) [ Time Frame: Change from baseline to week 10 ]
Original Secondary Outcome: Same as current
Information By: Children's Hospital Medical Center, Cincinnati
Dates:
Date Received: July 26, 2013
Date Started: June 2013
Date Completion: February 2017
Last Updated: September 6, 2016
Last Verified: September 2016
