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Open Label Study of Safety/Tolerability of Once Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Patients That Have and Have Not Been Previously Maintained on Twice-nightly Sodium Oxybate IR

Trial Profile

Open Label Study of Safety/Tolerability of Once Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Patients That Have and Have Not Been Previously Maintained on Twice-nightly Sodium Oxybate IR

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2024

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At a glance

  • Drugs Sodium oxybate (Primary) ; Sodium oxybate
  • Indications Cataplexy; Narcolepsy
  • Focus Adverse reactions; Registrational
  • Acronyms RESTORE
  • Sponsors Avadel Pharmaceuticals

Most Recent Events

  • 03 Sep 2024 According to an Avadel Pharmaceuticals media release, data from this trial were published in the Sleep Medicine: X.
  • 03 Sep 2024 Results presented in the Avadel Pharmaceuticals Media Release.
  • 22 May 2024 According to an Avadel Pharmaceuticals media release, end-of-study survey data from this trial will be presented at the SLEEP 2024, the 38th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society on June 1-5, 2024, in Houston.

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