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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2023

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At a glance

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

    • 08 Nov 2023 Results of Post hoc analyses evaluating efficacy of extended-release once-nightly sodium oxybate vs placebo for daytime sleepiness and disrupted nighttime sleep in narcolepsy type 1 and 2, published in the Sleep
    • 08 Nov 2023 According to an Avadel Pharmaceuticals media release, Post-hoc analyses from phase 3 REST-ON trial presented at World Sleep 2023
    • 20 Oct 2023 According to an Avadel Pharmaceuticals media release, Post-hoc analyses reinforcing data from the completed pivotal Phase 3 REST-ON trial will be presented at World Sleep 2023, being held from October 20-25, 2023 in Rio de Janeiro, Brazil.
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