An Open Label Study of FT218 in Subjects With Narcolepsy

Completed · Phase 3

Conditions studied: Narcolepsy, Cataplexy, Excessive Daytime Somnolence, Sleep Disorder, Sleep Disturbance, Sleep Wake Disorders

In brief

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

Key facts

Study ID

NCT04451668

Run by

Avadel

People needed

184

Starts

2020-06-12

Expected to finish

2024-11-18

Last updated by the study team

2025-10-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sleep Disorders Center of Alabama — Birmingham, Alabama, United States
• Stanford Sleep Medicine — Redwood City, California, United States
• SDS Clinical Trials — Santa Ana, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Delta Waves, Inc. — Colorado Springs, Colorado, United States
• Pulmonary Disease Specialists, PA — Kissimmee, Florida, United States
• Sleep Medicine Specialists of South Florida — Miami, Florida, United States
• FL Pediatric Research Institute — Winter Park, Florida, United States
• NeuroTrials Research Inc — Atlanta, Georgia, United States
• SleepCare Research Institute, Inc. d/b/a Clinical Research Institute — Stockbridge, Georgia, United States
• Fort Wayne Neurological — Fort Wayne, Indiana, United States
• Helene A. Emsellem, MD PC — Chevy Chase, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• St. Luke's Hospital - Sleep Medicine and Research Center — Chesterfield, Missouri, United States
• Montefiore Sleep-Wake Disorders Center — The Bronx, New York, United States
• Advanced Respiratory and Sleep Medicine — Huntersville, North Carolina, United States
• Sleep Management Institute Intrepid Research — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Ohio Sleep Medicine Institute — Dublin, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Brian Abaluck Sleep Medicine — Malvern, Pennsylvania, United States
• Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States
• Sleep Therapy & Research Center — San Antonio, Texas, United States
• Comprehensive Sleep Medicine Associates — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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