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

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ClinicalTrials.gov Identifier: NCT02720744
Recruitment Status : Recruiting
First Posted : March 28, 2016
Last Update Posted : March 13, 2018
Information provided by (Responsible Party):
Flamel Ireland Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Excessive Daytime Sleepiness Cataplexy Narcolepsy Drug: Sodium Oxybate Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy
Actual Study Start Date : November 2016
Estimated Primary Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sodium Oxybate
Patients will undergo a screening period and will then be titrated to the following daily doses: 4.5 g sodium oxybate, 6.0 g sodium oxybate, 7.5 g sodium oxybate, and 9.0 g sodium oxybate.
Drug: Sodium Oxybate
Placebo Comparator: Placebo
Patients will undergo a screening period and will then be titrated to the following daily doses: 4.5 g placebo, 6.0 g placebo, 7.5 g placebo, and 9.0 g placebo.
Drug: Placebo

Primary Outcome Measures :
  1. Longer MWT sleep latency [ Time Frame: 13 weeks ]
    MWT is the mean latency across 5 naps, averaged over the test day

  2. Improvement in CGI sleepiness scores [ Time Frame: 13 weeks ]
    Clinician's global impression of improvement in daytime sleepiness from screening

  3. Fewer cataplexy attacks as recorded by Sleep and Symptom Daily Diary [ Time Frame: 13 weeks ]
    Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period

Secondary Outcome Measures :
  1. Fewer PSG transitions from N1, N2, N3, and REM sleep to wake sleep and from N2, N3, and REM sleep to N1 [ Time Frame: 13 weeks ]
    Tested as part of the step down procedure based on the same statistical model used for the primary outcome measure

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    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
  7. Addition inclusion criteria per protocol

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:

    1. Anticonvulsants
    2. Clonidine
    3. SSRIs and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
    4. MAOIs
    5. TCAs
    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
  6. Additional exclusion criteria per protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720744

Contact: Siobhan O'Daly +353 1 4851210 clinicaltrials@flamel.com
Contact: Philip Matson +353 1 4851217 clinicaltrials@flamel.com

  Show 64 Study Locations
Sponsors and Collaborators
Flamel Ireland Limited

Additional Information:
Responsible Party: Flamel Ireland Limited
ClinicalTrials.gov Identifier: NCT02720744     History of Changes
Other Study ID Numbers: CLFT218-1501
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sodium Oxybate
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs