At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 184 enrolled
Drug / intervention
FT218drug
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.
Open Label Study of Safety/Tolerability of Once Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Patients That Have and Have Not Been Previously Maintained on Twice-nightly Sodium Oxybate IR
In Brief
A Phase 3 clinical trial evaluating FT218 for Narcolepsy and 5 related conditions. Completed, enrolled 184 participants across 29 sites in 2 countries.
Detailed Summary
An Open Label 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 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder, Sleep Disturbance, Sleep Wake Disorders
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartJun 2020
First PostedJun 2020
Primary CompletionDec 2023
Study CompletionNov 2024
TodayJul 2026
First PostedJun 30, 2020
Enrollment StartJun 12, 2020
Primary CompletionDec 22, 2023
Study CompletionNov 18, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.0 years ago
Interventions
FT218drug
once nightly sodium oxybate extended release