Phase 3 Study to Assess the Efficacy and Safety of a Nightly Extended-Release Formulation of Sodium Oxybate for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

Phase

N/A

Condition

Narcolepsy

Treatment

N/A

Clinical Study ID

TX208928

Ages 16-90
All Genders

Study Summary

This study is double-blind and placebo controlled and intended 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. This study will be 14-17 weeks long and requires overnight visits.

Eligibility Criteria

Inclusion

Subjects must be 16 years of age and older and must have documented evidence of a diagnosis of narcolepsy type 1 or narcolepsy type 2 as determined by an overnight PSG and next-day MSLT with mean sleep latency <8 minutes. Subjects must have current continuing presence of excessive daytime sleepiness for at least 3 months before starting the study. No prior use of sodium oxybate allowed.