Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

The purpose of this study is to determine whether aFT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Enrollment: 264
Study Start Date: July 2016
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Sodium Oxybate
- Placebo Comparator: Placebo