Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

Last updated: March 18, 2022
Sponsor: Avadel
Overall Status: Completed

Phase

3

Condition

Narcolepsy

Cataplexy

Treatment

N/A

Clinical Study ID

NCT02720744
CLFT218-1501
  • Ages > 16
  • All Genders

Study Summary

The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects 16 years of age or older

  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:

  7. They must be on a stable dose of stimulants for at least 3 weeks prior to starting the screening process for this study; AND

  8. They must use the same stimulant regimen throughout the entire study period, including during screening and posttreatment periods

  9. They must discontinue all anti cataplexy drugs

  10. Addition inclusion criteria per protocol

Exclusion criteria

  1. Any prior use of sodium oxybate is allowed in the study but within the following exclusions:

  2. Previous dosing must have been limited to no more than 4.5g per night

  3. Patient should not have taken sodium oxybate for more than 2 weeks.

  4. All previous dosing must not have occurred within the last year prior to entry to the study.

  5. Current use of sodium valproate

  6. Any use of the following prohibited medications for the duration of the clinical study:

  7. Anticonvulsants

  8. Clonidine

  9. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine re-uptake inhibitors (SNRIs)

  10. MAOIs (monoamine oxidase inhibitors)

  11. TCAs (tricyclic antidepressants)

  12. Hypnotics

  13. Anxiolytics

  14. Sedating antihistamines

  15. Antipsychotics

  16. Other experimental medications designed to treat narcolepsy, cataplexy or any other condition

  17. Treatment with any investigational products within 3 months before study enrollment

  18. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted

  19. Additional exclusion criteria per protocol

Study Design

Total Participants: 212
Study Start date:
November 17, 2016
Estimated Completion Date:
March 25, 2020

Connect with a study center

  • NHMRC CEntre for Translational Sleep and Circadian Neurobiology

    Sydney, New South Wales 2037
    Australia

    Site Not Available

  • Westmead Hospital

    Sydney, New South Wales NSW 2145
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland QLD 4102
    Australia

    Site Not Available

  • Flinders Medical Centre

    Adelaide, South Australia SA 5042
    Australia

    Site Not Available

  • Queen Elizabeth Hospital

    Adelaide, South Australia SA 5011
    Australia

    Site Not Available

  • Melbourne Sleep Disorders Centre

    Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Perth, Western Province 6009
    Australia

    Site Not Available

  • Somni Research Inc. Calgary

    Calgary, Alberta T2X 2A8
    Canada

    Site Not Available

  • Okanagan Clinical Trials Ltd

    Kelowna, British Columbia BC V1Y 1Z9
    Canada

    Site Not Available

  • Ottawa Hospital Civic Campus

    Ottawa, Ontario K1Y 4E9
    Canada

    Site Not Available

  • West Parry Sound Health Center

    Parry Sound, Ontario P2A 3A4
    Canada

    Site Not Available

  • Paediatric Sleep Research Inc

    Toronto, Ontario M5G 1N8
    Canada

    Site Not Available

  • Somni Research Inc

    Toronto, Ontario L3R 1A3
    Canada

    Site Not Available

  • CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal

    Montreal, Quebec 5400
    Canada

    Site Not Available

  • Vseobecna Facultni Nemocnice

    Praha, 212821
    Czechia

    Site Not Available

  • University of Copenhagen

    Copenhagen, DK-2600
    Denmark

    Site Not Available

  • Helsinki Sleep Clinic

    Helsinki, 00380
    Finland

    Site Not Available

  • CHU Michallon

    Grenoble, 938043
    France

    Site Not Available

  • Hospital Roger Salengro

    Lille, 59037
    France

    Site Not Available

  • Hospital Gui-de-de-Chauliac

    Montpellier, 34295
    France

    Site Not Available

  • INSERM - Centre d'Investigation Clinque Hopital Robert Debre

    Paris, 75019
    France

    Site Not Available

  • Hospital Haut Leveque

    Pessac, 33600
    France

    Site Not Available

  • Charit Universittsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • HELIOS-Klinik Hagen-Ambrock

    Hagen, 58091
    Germany

    Site Not Available

  • Universitatsklinikum Munster. Klinik fur Schlafmedizin und Neuromuskulare Erkrankungen

    Munster,
    Germany

    Site Not Available

  • Hephata Klinik

    Schwalmstadt, 34131
    Germany

    Site Not Available

  • Somni bene GmbH

    Schwerin, 19053
    Germany

    Site Not Available

  • Sleep Wake Center SEIN Heemstede

    Heemstede, 2103 SW
    Netherlands

    Site Not Available

  • Klinik Barmelweid

    Barmelweid, 5017
    Switzerland

    Site Not Available

  • Universitaetsspital Bern- Inselspital - Universitaetsklinik fuer Neuologie

    Bern, 3010
    Switzerland

    Site Not Available

  • Neurocenter of Southern Switzerland Sleep and Epilepsy Center

    Lugano, 6900
    Switzerland

    Site Not Available

  • Nevill Hall Hospital Sleep and Respiratory Medicine Aneurin Bevan Sleep Centre

    Abergavenny, Wales NP7 7EG
    United Kingdom

    Site Not Available

  • REspiratory Support and Sleep Centre at Papworth Hospital

    Cambridge, CB233RE
    United Kingdom

    Site Not Available

  • Aintree University Hospital NHS Foundation Trust

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • St Pancras Clinical Research

    London, WC1X 8QD
    United Kingdom

    Site Not Available

  • Pinnacle Research Group LLC

    Anniston, Alabama 36207
    United States

    Site Not Available

  • University Sleep Disorder Center

    Auburn, Alabama AL 36832
    United States

    Site Not Available

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama 35213
    United States

    Site Not Available

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • California Center for Sleep Disorders

    Alameda, California 94501
    United States

    Site Not Available

  • Southern California Institute for Respiratory Disease Inc

    Los Angeles, California CA 90048
    United States

    Site Not Available

  • SDS Clinical Trials Inc

    Orange, California 92868
    United States

    Site Not Available

  • Stanford Sleep Medicine

    Redwood City, California 94063
    United States

    Site Not Available

  • Sleep Medicine Specialists of California

    San Ramon, California 94583
    United States

    Site Not Available

  • SDS Clinical Trials Inc

    Santa Ana, California CA 92705
    United States

    Site Not Available

  • Southern California REsearch LLC

    Thousand Oaks, California 91360-3967
    United States

    Site Not Available

  • Alpine Research Center

    Boulder, Colorado 80301
    United States

    Site Not Available

  • Yale-New Haven Hospital's Sleep Medicine Center

    North Haven, Connecticut 06473
    United States

    Site Not Available

  • Pulmonary Disease Specialist, PA

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Sleep Medicine Specialist of South Florida

    Miami, Florida FL 33126
    United States

    Site Not Available

  • Sleep Medicine Specialists of South Florida

    Miami, Florida 33176
    United States

    Site Not Available

  • NeuroMedical Research Institute/Global Research Holdings, LLC

    Panama City, Florida FL 32405
    United States

    Site Not Available

  • Clinical Research Group of St Petersburg

    Saint Petersburg, Florida 33707
    United States

    Site Not Available

  • FL Pediatric REsearch Institute

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Florida Pulmonary Research Institute LLC

    Winter Park, Florida 32789
    United States

    Site Not Available

  • NeuroTrials Research Inc

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Sleep Disorders Center of Georgia

    Atlanta, Georgia GA 30342
    United States

    Site Not Available

  • Clinical Research Institute

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • OSF Healthcare Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana IN 46804
    United States

    Site Not Available

  • JWM Neurology

    Indianapolis, Indiana IN46256
    United States

    Site Not Available

  • Norton Clinical Research Group

    Louisville, Kentucky KY40218
    United States

    Site Not Available

  • Center for Sleep and Wake Disorders

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Infinity Medical Research

    North Dartmouth, Massachusetts MA 2747
    United States

    Site Not Available

  • Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Saint Louis, Missouri 63143
    United States

    Site Not Available

  • Montefiore Sleep-Wake Disorders Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Northwell Health

    New Hyde Park, New York NY 1040
    United States

    Site Not Available

  • Clinilabs Drug Development Corporation

    New York, New York NY10019
    United States

    Site Not Available

  • Pulmonary Health Physicians, PC

    Syracuse, New York 13210
    United States

    Site Not Available

  • Montefiore Sleep-Wake Disorders Center

    The Bronx, New York 10467
    United States

    Site Not Available

  • Research Carolina of Huntersville

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Wake Research Associates, LLC

    Raleigh, North Carolina NC 27612
    United States

    Site Not Available

  • Sleep Management Institute Intrepid Research

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio Sleep Medicine Institute

    Dublin, Ohio 43017
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Medical University of South Carolina - Institute of Psychiatry

    Charleston, South Carolina SC 29425
    United States

    Site Not Available

  • SleepMed Of South Carolina

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • Sleep and Neurology Consultants

    Houston, Texas 77063
    United States

    Site Not Available

  • Sleep Therapy Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Sound Sleep Health

    Kirkland, Washington 98034
    United States

    Site Not Available

  • Mid Columbia Clinical Research

    Richland, Washington WA 99352
    United States

    Site Not Available

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