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Clinical trial

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

NCT04451668 is registered in ClinicalTrials.gov with Avadel as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Avadel
Phase
Phase 3
Overall status
Completed
Start date
June 12, 2020
Completion date
November 18, 2024
Enrollment
184 (actual)
Sites
29

Conditions

As the registry lists them; a condition with its own page is linked.

cataplexy, excessive daytime somnolence, narcolepsy, sleep disorder, sleep disturbance, sleep wake disorders