At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 212 enrolled
Drug / intervention
FT218 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating FT218 and Placebo for Excessive Daytime Sleepiness and 2 related conditions. Completed, enrolled 212 participants across 57 sites in 6 countries.
Detailed Summary
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExcessive Daytime Sleepiness, Cataplexy, Narcolepsy
CountriesAustralia, Canada, Czechia, France, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartNov 2016
Primary CompletionMar 2020
TodayJul 2026
First PostedMar 28, 2016
Enrollment StartNov 17, 2016
Primary CompletionMar 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.3 years ago
Interventions
FT218drug
Placebodrug