Clinical Trial: Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218

Brief Summary: The purpose of this study is to determine whether FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

Detailed Summary:
Sponsor: Flamel Ireland Limited

Current Primary Outcome:

  • Longer MWT sleep latency [ Time Frame: 13 weeks ]
    MWT is the mean latency across 5 naps, averaged over the test day
  • Improvement in CGI sleepiness scores [ Time Frame: 13 weeks ]
    Clinician's global impression of improvement in daytime sleepiness from screening
  • Fewer cataplexy attacks as recorded by Sleep and Symptom Daily Diary [ Time Frame: 13 weeks ]
    Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period


Original Primary Outcome: Same as current

Current Secondary Outcome: Fewer PSG transitions from N1, N2, N3, and REM sleep to wake sleep and from N2, N3, and REM sleep to N1 [ Time Frame: 13 weeks ]

Tested as part of the step down procedure based on the same statistical model used for the primary outcome measure


Original Secondary Outcome: Same as current

Information By: Flamel Ireland Limited

Dates:
Date Received: March 22, 2016
Date Started: July 2016
Date Completion:
Last Updated: May 10, 2017
Last Verified: May 2017