Narcolepsy Treatment Study
Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the Ability to Switch from Twice-Nightly Immediate Release Sodium Oxybate to Once-Nightly FT218, or to begin once-Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy
HEALTHY PARTICIPANTS: Yes
CONDITION: Narcolepsy, Cataplexy, Sleep Disorder
Purpose of Study
The purpose of this research study is to understand how safe the investigational drug is and how effective the drug is in reducing excessive daytime sleepiness and cataplexy in subjects with narcolepsy when taken long-term. The study will also evaluate how patients with narcolepsy who are or are not already on twice-nightly sodium oxybate or mixed salts oxybate can switch to FT218 in terms of what dosage should be prescribed.
Who Can Participate?
Individuals who are 16 years and older and are diagnosed with narcolepsy may be eligible for this study.