Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
NCT ID: NCT02720744
Last Updated: 2022-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
212 participants
INTERVENTIONAL
2016-11-17
2020-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sodium Oxybate
Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g sodium oxybate, 6.0 g sodium oxybate, 7.5 g sodium oxybate, and 9.0 g sodium oxybate.
FT218
Placebo
Patients will undergo a screening period and will then be titrated to the following once-nightly doses: 4.5 g placebo, 6.0 g placebo, 7.5 g placebo, and 9.0 g placebo.
Placebo
Interventions
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FT218
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Willing and able to give written informed consent for study participation. For young adults (16 and 17 years old) who have not reached the age of majority they must be capable of giving assent and consent from a legally authorized guardian must be obtained, as required by local laws and regulations
3. Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2 narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with mean sleep latency in the pathological range i.e. \< 8 minutes and meeting the NT1 and NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
4. Current continuing presence of EDS (excessive daytime sleepiness) as defined by subject report for the last 3 months and an ESS (Epworth sleepiness scale) \> 10
5. For NT1 only, current continuing presence of cataplexy as defined by subject report for the last 3 months
6. Subjects may use concomitant stimulants, but must comply with the following:
1. They must be on a stable dose of stimulants for at least 3 weeks prior to starting the screening process for this study; AND
2. They must use the same stimulant regimen throughout the entire study period, including during screening and posttreatment periods
3. They must discontinue all anti cataplexy drugs
Exclusion Criteria
1. Previous dosing must have been limited to no more than 4.5g per night
2. Patient should not have taken sodium oxybate for more than 2 weeks.
3. All previous dosing must not have occurred within the last year prior to entry to the study.
2. Current use of sodium valproate
3. Any use of the following prohibited medications for the duration of the clinical study:
1. Anticonvulsants
2. Clonidine
3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
4. MAOIs (monoamine oxidase inhibitors)
5. TCAs (tricyclic antidepressants)
6. Hypnotics
7. Anxiolytics
8. Sedating antihistamines
9. Antipsychotics
10. Other experimental medications designed to treat narcolepsy, cataplexy or any other condition
4. Treatment with any investigational products within 3 months before study enrollment
5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
16 Years
ALL
No
Sponsors
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Avadel
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group LLC
Anniston, Alabama, United States
University Sleep Disorder Center
Auburn, Alabama, United States
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
California Center for Sleep Disorders
Alameda, California, United States
Stanford Sleep Medicine
Redwood City, California, United States
SDS Clinical Trials Inc
Santa Ana, California, United States
Alpine Research Center
Boulder, Colorado, United States
Yale-New Haven Hospital's Sleep Medicine Center
North Haven, Connecticut, United States
Pulmonary Disease Specialist, PA
Kissimmee, Florida, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, United States
Sleep Medicine Specialist of South Florida
Miami, Florida, United States
NeuroMedical Research Institute/Global Research Holdings, LLC
Panama City, Florida, United States
FL Pediatric REsearch Institute
Winter Park, Florida, United States
Florida Pulmonary Research Institute LLC
Winter Park, Florida, United States
NeuroTrials Research Inc
Atlanta, Georgia, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States
Clinical Research Institute
Stockbridge, Georgia, United States
OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Norton Clinical Research Group
Louisville, Kentucky, United States
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
Infinity Medical Research
North Dartmouth, Massachusetts, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Northwell Health
New Hyde Park, New York, United States
Clinilabs Drug Development Corporation
New York, New York, United States
Montefiore Sleep-Wake Disorders Center
The Bronx, New York, United States
Research Carolina of Huntersville
Huntersville, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Sleep Management Institute Intrepid Research
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Medical University of South Carolina - Institute of Psychiatry
Charleston, South Carolina, United States
SleepMed Of South Carolina
Columbia, South Carolina, United States
Sleep and Neurology Consultants
Houston, Texas, United States
Sleep Therapy Research Center
San Antonio, Texas, United States
NHMRC CEntre for Translational Sleep and Circadian Neurobiology
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Melbourne Sleep Disorders Centre
Melbourne, Victoria, Australia
Somni Research Inc. Calgary
Calgary, Alberta, Canada
Okanagan Clinical Trials Ltd
Kelowna, British Columbia, Canada
West Parry Sound Health Center
Parry Sound, Ontario, Canada
Somni Research Inc
Toronto, Ontario, Canada
Paediatric Sleep Research Inc
Toronto, Ontario, Canada
CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Vseobecna Facultni Nemocnice
Prague, , Czechia
CHU Michallon
Grenoble, , France
Hospital Gui-de-de-Chauliac
Montpellier, , France
INSERM - Centre d'Investigation Clinque Hopital Robert Debre
Paris, , France
Charit Universittsmedizin Berlin
Berlin, , Germany
Hephata Klinik
Schwalmstadt, , Germany
Somni bene GmbH
Schwerin, , Germany
Countries
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References
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Ortiz LE, Morse AM, Thorpy MJ, Kushida CA, Harsh J, Roth T, Gudeman J, Dauvilliers Y. Once-Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy. J Sleep Res. 2025 Aug 25:e70189. doi: 10.1111/jsr.70189. Online ahead of print.
Roth T, Thorpy MJ, Kushida CA, Gudeman J. Efficacy of Once-Nightly Sodium Oxybate in Patients with Narcolepsy: Post Hoc Analyses of Sensitivity, Effect Size, and Numbers Needed to Treat from the Phase 3 REST-ON Trial. CNS Drugs. 2025 Mar;39(Suppl 1):61-70. doi: 10.1007/s40263-025-01160-0. Epub 2025 Mar 20.
Krahn L, Roy A, Winkelman JW, Morse AM, Gudeman J. Assessing Early Efficacy After Initiation of Once-Nightly Sodium Oxybate (ON-SXB; FT218) in Participants with Narcolepsy Type 1 or 2: A Post Hoc Analysis from the Phase 3 REST-ON Trial. CNS Drugs. 2025 Mar;39(Suppl 1):53-59. doi: 10.1007/s40263-024-01143-7. Epub 2025 Mar 20.
Dauvilliers Y, Roth T, Bogan R, Thorpy MJ, Morse AM, Roy A, Gudeman J. Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phase 3 REST-ON trial. Sleep Med. 2024 Dec;124:209-216. doi: 10.1016/j.sleep.2024.09.024. Epub 2024 Sep 17.
Roth T, Morse AM, Bogan R, Roy A, Gudeman J, Dauvilliers Y. Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial. Clin Ther. 2024 Oct;46(10):791-798. doi: 10.1016/j.clinthera.2024.07.010. Epub 2024 Aug 16.
Roth T, Dauvilliers Y, Thorpy MJ, Kushida C, Corser BC, Bogan R, Rosenberg R, Dubow J, Seiden D. Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial. CNS Drugs. 2022 Apr;36(4):377-387. doi: 10.1007/s40263-022-00904-6. Epub 2022 Apr 5.
Kushida CA, Shapiro CM, Roth T, Thorpy MJ, Corser BC, Ajayi AO, Rosenberg R, Roy A, Seiden D, Dubow J, Dauvilliers Y. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022 Jun 13;45(6):zsab200. doi: 10.1093/sleep/zsab200.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLFT218-1501
Identifier Type: -
Identifier Source: org_study_id
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