Clinical Trial: Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragi
Brief Summary: The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be safe and well tolerated.
Detailed Summary:
Sponsor: Seaside Therapeutics, Inc.
Current Primary Outcome: Aberrant Behavior Checklist Irritability Subscore [ Time Frame: After 4 weeks of treatment ]
Original Primary Outcome:
- Adverse events [ Time Frame: during the study ]
- Aberrant Behavior Checklist Irritability Subscore [ Time Frame: After 4 weeks of treatment ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Seaside Therapeutics, Inc.
Dates:
Date Received: November 7, 2008
Date Started: November 2008
Date Completion:
Last Updated: March 22, 2013
Last Verified: March 2013