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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-006271
    NCT ID: NCT02720744
    Sponsor Protocol Number: CLFT218-1501

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lois Krahn, M.D.

Open for enrollment

Contact information:

Erica Boyd R.N., CCRP

(480)342-1316

Boyd.Erica@mayo.edu