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 ]

The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).


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