Clinical Trial: A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title:

Brief Summary: The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.

Detailed Summary:
Sponsor: Jazz Pharmaceuticals

Current Primary Outcome:

  • Efficacy of Xyrem [ Time Frame: 2 Weeks ]
    Change in weekly number of cataplexy attacks (2 weeks). Two week double-blind comparison
  • Xyrem Safety In Participants [ Time Frame: Up to 52 weeks ]
    Adverse events will be summarized by treatment Group and by dose.


Original Primary Outcome: Same as current

Current Secondary Outcome: To Evaluate the efficacy of xyrem in the treatment of excessive daytimne sleepiness (EDS) in pediatric subjects with narcolepsy with cataplexy [ Time Frame: 2 Weeks ]

Clinical Global Impression of Change (CGIc) for cataplexy severity. Change in the Epworth Sleepiness Scale for CHildren and Adolescents (ESS [CHAD}) score


Original Secondary Outcome: Same as current

Information By: Jazz Pharmaceuticals

Dates:
Date Received: July 28, 2014
Date Started: September 2014
Date Completion: December 2017
Last Updated: October 11, 2016
Last Verified: October 2016