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

Last updated: January 4, 2018
Sponsor: Flamel Ireland Limited
Overall Status: Active - Recruiting

Phase

3

Condition

Cataplexy

Narcolepsy

Treatment

Sodium Oxybate

Placebo

Clinical Study ID

NCT02720744
  • Ages 16-100
  • All Genders

Study Summary

The purpose of this study is to determine whether 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 or NT2 as, in part, determined by an overnight PSG and next-day MSLT with 2 or more SOREMPs 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 as defined by subject report for the last 3 months and an ESS > 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

Exclusion criteria

  1. Any prior use of sodium oxybate
  2. Current use of sodium valproate
  3. Any use of the following prohibited medications for the duration of the clinical study
  • Anticonvulsants
  • Clonidine
  • SSRIs and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
  • MAOIs
  • TSAs
  • Hypnotics
  • Anxiolytics
  • Sedating antihistamines
  • Antipsychotics
  • Other experimental medications designed to treat narcolepsy, cataplexy or any other condition
  • Treatment with any investigational products within 3 months before study enrollment
  • Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted.

4. Additional exclusion criteria per protocol

Study Design

Total Participants: 264
Treatment Group(s): 2
Primary Treatment: Sodium Oxybate
Phase: 3
Study Start date:
Estimated Completion Date:

Study Description

Connect with a study center

  • Somni Research Inc. Calgary

    Calgary, Alberta T2X 2A8
    Canada

    Active - Recruiting

    1,683.36 miles

  • Okanagan Clinical Trials Ltd

    Kelowna, British Columbia BC V1Y 1Z9
    Canada

    Active - Recruiting

    1,921.86 miles

  • Ottawa Hospital Civic Campus

    Ottawa, Ontario K1Y 4E9
    Canada

    Active - Recruiting

    216.98 miles

  • Paediatric Sleep Research Inc

    Toronto, Ontario M5G 1N8
    Canada

    Active - Recruiting

    0.81 miles

  • Somni Research Inc

    Toronto, Ontario L3R 1A3
    Canada

    Active - Recruiting

    11.76 miles

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

    Montreal, Quebec 5400
    Canada

    Active - Recruiting

    313.46 miles

  • University of Copenhagen

    Copenhagen, DK-2600
    Denmark

    Active - Recruiting

    3,878.17 miles

  • Helsinki Sleep Clinic

    Helsinki, 00380
    Finland

    Active - Recruiting

    4,097.08 miles

  • Hospital Roger Salengro

    Lille, 59037
    France

    Active - Recruiting

    3,872.85 miles

  • Hospital Gui-de-de-Chauliac

    Montpellier, 34295
    France

    Active - Recruiting

    3,971.45 miles

  • INSERM - Centre d'Investigation Clinque Hopital Robert Debre

    Paris, 75019
    France

    Active - Recruiting

    3,729.09 miles

  • Hospital Haut Leveque

    Pessac, 33600
    France

    Active - Recruiting

    3,736.36 miles

  • Charit Universittsmedizin Berlin

    Berlin, 10117
    Germany

    Active - Recruiting

    4,023.48 miles

  • HELIOS-Klinik Hagen-Ambrock

    Hagen, 58091
    Germany

    Active - Recruiting

    3,847.67 miles

  • Universitatsklinikum Munster. Klinik fur Schlafmedizin und Neuromuskulare Erkrankungen

    Munster,
    Germany

    Active - Recruiting

    3,832.29 miles

  • Hephata Klinik

    Schwalmstadt, 34131
    Germany

    Active - Recruiting

    3,927.7 miles

  • Somni bene GmbH

    Schwerin, 19053
    Germany

    Active - Recruiting

    3,913.58 miles

  • Sleep Wake Center SEIN Heemstede

    Heemstede, 2103 SW
    Netherlands

    Active - Recruiting

    3,707.4 miles

  • Klinik Barmelweid

    Barmelweid, 5017
    Switzerland

    Active - Recruiting

    4,002.96 miles

  • Neurocenter of Southern Switzerland Sleep and Epilepsy Center

    Lugano, 6900
    Switzerland

    Active - Recruiting

    4,094.09 miles

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

    Abergavenny, NP7 7EG
    United Kingdom

    Active - Recruiting

    3,426.76 miles

  • REspiratory Support and Sleep Centre at Papworth Hospital

    Cambridge, CB233RE
    United Kingdom

    Active - Recruiting

    3,529.13 miles

  • Guy's Hospital

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

    3,551.28 miles

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama 35213
    United States

    Active - Recruiting

    804.76 miles

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

    1,872.17 miles

  • SDS Clinical Trials Inc

    Orange, California 92868
    United States

    Active - Recruiting

    2,161.88 miles

  • Stanford Sleep Medicine

    Redwood City, California 94063
    United States

    Active - Recruiting

    2,261.82 miles

  • Sleep Medicine Specialists of California

    San Ramon, California 94583
    United States

    Active - Recruiting

    2,241.19 miles

  • Colorado Sleep Institute

    Boulder, Colorado 80301
    United States

    Active - Recruiting

    1,346.64 miles

  • Yale-New Haven Hospital's Sleep Medicine Center

    North Haven, Connecticut 06473
    United States

    Active - Recruiting

    366.96 miles

  • Pulmonary Disease Specialist, PA

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

    1,066.1 miles

  • Clinical Trials of Florida

    Miami, Florida 33186
    United States

    Active - Recruiting

    1,243.52 miles

  • Sleep Medicine Specialist of South Florida

    Miami, Florida FL 33126
    United States

    Active - Recruiting

    1,235.7 miles

  • Clinical Research Group of St Petersburg

    Saint Petersburg, Florida 33707
    United States

    Active - Recruiting

    1,113.67 miles

  • FL Pediatric REsearch Institute

    Winter Park, Florida 32789
    United States

    Active - Recruiting

    1,045.56 miles

  • Florida Pulmonary Research Institute LLC

    Winter Park, Florida 32789
    United States

    Active - Recruiting

    1,045.56 miles

  • NeuroTrials Research Inc

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

    725.86 miles

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana IN 46804
    United States

    Active - Recruiting

    348.56 miles

  • Kentucky Research Group

    Louisville, Kentucky KY40218
    United States

    Active - Recruiting

    499.24 miles

  • Chesterfield, Missouri 63017
    United States

    Active - Recruiting

    674.29 miles

  • Saint Louis, Missouri 63143
    United States

    Active - Recruiting

    666.31 miles

  • Research Carolina of Huntersville

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

    575.26 miles

  • Raleigh Neurology Associates

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

    543.43 miles

  • Sleep Management Institute Intrepid Research

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

    405.49 miles

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

    186.12 miles

  • Ohio Sleep Medicine Institute

    Dublin, Ohio 43017
    United States

    Active - Recruiting

    310.73 miles

  • Geisinger Medical CEnter

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

    233.42 miles

  • SleepMed Of South Carolina

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

    672.44 miles

  • Sleep and Neurology Consultants

    Houston, Texas 77063
    United States

    Active - Recruiting

    1,308.02 miles

  • Sleep Therapy Research Center

    San Antonio, Texas 78229
    United States

    Active - Recruiting

    1,438.36 miles

  • Sound Sleep Health

    Kirkland, Washington 98034
    United States

    Active - Recruiting

    2,058.67 miles

  • Mid Columbia Clinical Research

    Richland, Washington WA 99352
    United States

    Active - Recruiting

    1,939.07 miles

  • Vseobecna Facultni Nemocnice

    Praha, 212821

    Active - Recruiting

    4,152.84 miles

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