An Open Label Study of FT218 in Subjects With Narcolepsy
NCT ID: NCT04451668
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
184 participants
INTERVENTIONAL
2020-06-12
2024-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FT218
once nightly sodium oxybate extended release oral solution (FT218)
FT218
once nightly sodium oxybate extended release
Interventions
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FT218
once nightly sodium oxybate extended release
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
16 Years
ALL
No
Sponsors
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Avadel
INDUSTRY
Responsible Party
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Locations
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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
Northwest Houston Neurology
Tomball, Texas, United States
TPMG Clinical Research Williamsburg
Williamsburg, Virginia, United States
West Perry Sound Health Center
Parry Sound, Ontario, Canada
Jodha Tishon Inc.
Toronto, Ontario, Canada
Countries
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References
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Roy A, Stern T, Harsh J, Hudson JD, Ajayi AO, Corser BC, Mignot E, Santamaria A, Morse AM, Abaluck B, Ibrahim S, Schweitzer PK, Lancaster K, Dubow J, Gudeman J. RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates. Sleep Med X. 2024 Aug 15;8:100122. doi: 10.1016/j.sleepx.2024.100122. eCollection 2024 Dec 15.
Other Identifiers
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CLFT218-1901
Identifier Type: -
Identifier Source: org_study_id
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