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Study identifier: NCT04451668 Synced from ClinicalTrials.gov · July 28, 2026
● Completed

An Open Label Study of FT218 in Subjects With Narcolepsy

Condition: Narcolepsy · Cataplexy · Excessive Daytime Somnolence  ·  Sponsor: Avadel

PhasePhase 3
Planned participants184
Who can joinAll sexes, 16 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (29)

Sleep Disorders Center of AlabamaBirmingham, Alabama, United States
Stanford Sleep MedicineRedwood City, California, United States
SDS Clinical TrialsSanta Ana, California, United States
Alpine Clinical Research CenterBoulder, Colorado, United States
Delta Waves, Inc.Colorado Springs, Colorado, United States
Pulmonary Disease Specialists, PAKissimmee, Florida, United States
Sleep Medicine Specialists of South FloridaMiami, Florida, United States
FL Pediatric Research InstituteWinter Park, Florida, United States
NeuroTrials Research IncAtlanta, Georgia, United States
SleepCare Research Institute, Inc. d/b/a Clinical Research InstituteStockbridge, Georgia, United States
Fort Wayne NeurologicalFort Wayne, Indiana, United States
Helene A. Emsellem, MD PCChevy Chase, Maryland, United States

+ 17 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04451668