An Open Label Study of FT218 in Subjects With Narcolepsy
Key facts
- Where
- Atlanta, Austin, Birmingham, Boulder, Chesterfield, Chevy Chase, Cincinnati, Cleveland, Colorado Springs, Columbia, Danville, Dublin, Fort Wayne, Huntersville, Kissimmee, Malvern, Miami, Redwood City, San Antonio, Santa Ana, Springfield, Stockbridge, Sugar Land, The Bronx, Tomball, Williamsburg, and Winter Park, United StatesSee the 27 sites
- Phase
- Phase 3
Where in United States
- NeuroTrials Research IncAtlanta, United StatesNo longer taking part
- FutureSearch Trials of NeurologyAustin, United StatesNo longer taking part
- Sleep Disorders Center of AlabamaBirmingham, United StatesNo longer taking part
- Alpine Clinical Research CenterBoulder, United StatesNo longer taking part
- St. Luke's Hospital - Sleep Medicine and Research CenterChesterfield, United StatesNo longer taking part
- Helene A. Emsellem, MD PCChevy Chase, United StatesNo longer taking part
- Sleep Management Institute Intrepid ResearchCincinnati, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- Delta Waves, Inc.Colorado Springs, United StatesNo longer taking part
- Bogan Sleep Consultants, LLCColumbia, United StatesNo longer taking part
- Geisinger Medical CenterDanville, United StatesNo longer taking part
- Ohio Sleep Medicine InstituteDublin, United StatesNo longer taking part
- Fort Wayne NeurologicalFort Wayne, United StatesNo longer taking part
- Advanced Respiratory and Sleep MedicineHuntersville, United StatesNo longer taking part
- Pulmonary Disease Specialists, PAKissimmee, United StatesNo longer taking part
- Brian Abaluck Sleep MedicineMalvern, United StatesNo longer taking part
- Sleep Medicine Specialists of South FloridaMiami, United StatesNo longer taking part
- Stanford Sleep MedicineRedwood City, United StatesNo longer taking part
- Sleep Therapy Research CenterSan Antonio, United StatesNo longer taking part
- SDS Clinical TrialsSanta Ana, United StatesNo longer taking part
- Baystate Medical CenterSpringfield, United StatesNo longer taking part
- SleepCare Research Institute, Inc. d/b/a Clinical Research InstituteStockbridge, United StatesNo longer taking part
- Comprehensive Sleep Medicine AssociatesSugar Land, United StatesNo longer taking part
- Montefiore Sleep-Wake Disorders CenterThe Bronx, United StatesNo longer taking part
- Northwest Houston NeurologyTomball, United StatesNo longer taking part
- TPMG Clinical Research WilliamsburgWilliamsburg, United StatesNo longer taking part
- FL Pediatric Research InstituteWinter Park, United StatesNo longer taking part
Trial details
- Who runs it
- Avadel
- Trial code
- NCT04451668
- Record updated
- 2 October 2025
- Original description
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 NarcolepsyRead full original descriptionShow less
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
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
Inclusion: Subjects receiving a stable doses of twice-nightly sodium oxybate IR or mixed salts oxybate for at least 4 weeks and are willing to switch to FT218; Subjects who completed the CLFT218-1501 REST-ON Study in a compliant manner and for whom the Investigator determines would receive benefit from treatment with FT218 and have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate; Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate IR or mixed salts oxybate); Subjects have a diagnosis of narcolepsy, either confirmed prior to the REST-ON study or as confirmed by the Investigator as defined by the International Classification of Sleep Disorders 3 criteria (AASM 2014); Willing and able to give written informed consent for study participation. Young adults (16 and 17 years old) who have not reached the age of majority must be capable of giving assent in addition to consent from a legally authorized guardian, as required by local laws and regulations.
Exclusion: Subjects that terminated the CLFT218-1501 REST-ON Study prior to completing Visit 8; Any use of the following medications during the study: Anticonvulsants, Clonidine, Hypnotics, Anxiolytics, Sedating antihistamines, Antipsychotics, Other experimental medications designed to treat narcolepsy, cataplexy or any other condition, or other medications with significant sedating effects/CNS depressant effects are prohibited for REST-ON and naive patients. Patients on twice nightly sodium oxybate IR on medications in classes listed above may be eligible for enrollment if the subject has been on a stable dose of the prohibited medication in combination with a stable dose of twice nightly sodium oxybate or mixed salts oxybate for at least three months and has demonstrated no AEs, intolerance, or interactions AND is approved to participate by the Medical Monitor. Sedative hypnotics are prohibited regardless.); A diagnosis of sleep apnea where AHI is ≥15 and/or current use of CPAP or other devices for sleep apnea.