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: 16 Aug 2017

At a glance

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

    • 24 May 2017 Planned primary completion date changed from 1 Jul 2017 to 1 Jan 2018.
    • 09 May 2017 According to an AVADEL Pharmaceuticals media release, the company has began site initiations in the USA.
    • 05 Jan 2017 According to an AVADEL Pharmaceuticals media release, the company expects to complete the enrollment by year-end 2017.
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