Phase 3 Study to Assess the Efficacy and Safety of a Nightly Extended-Release Formulation of Sodium Oxybate for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting







Clinical Study ID

  • Ages 16-90
  • All Genders

Study Summary

This study is double-blind and placebo controlled and intended to assess the efficacy and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension (FT218) for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy. This study will be 14-17 weeks long and requires overnight visits.

Eligibility Criteria


Subjects must be 16 years of age and older and must have documented evidence of a diagnosis of narcolepsy type 1 or narcolepsy type 2 as determined by an overnight PSG and next-day MSLT with mean sleep latency <8 minutes. Subjects must have current continuing presence of excessive daytime sleepiness for at least 3 months before starting the study. No prior use of sodium oxybate allowed.

Study Design

Study Start date:
Estimated Completion Date:

Study Description