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
Phase of Trial: Phase III
Latest Information Update: 15 Dec 2017
At a glance
- Drugs Sodium oxybate (Primary)
- Indications Narcolepsy
- Focus Registrational; Therapeutic Use
- Acronyms Rest-On
- Sponsors Flamel Technologies
- 30 Aug 2017 Planned primary completion date changed from 1 Jan 2018 to 1 Apr 2018.
- 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.