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) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

Trial Profile

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) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Apr 2018

At a glance

  • Drugs Sodium oxybate (Primary)
  • Indications Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms Rest-On
  • Sponsors Flamel Technologies
  • Most Recent Events

    • 10 Jan 2018 According to an Avadel Pharmaceuticals media release, the company is looking forward to complete the trial this year 2018.
    • 29 Dec 2017 According to an Avadel Pharmaceuticals media release, the company expects to file an NDA with the US FDA by the end of 2018.
    • 30 Aug 2017 Planned primary completion date changed from 1 Jan 2018 to 1 Apr 2018.
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