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.



Eligible Ages
Over 16 Years
Eligible Genders
Accepts Healthy Volunteers

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 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 and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
  10. MAOIs
  11. TCAs
  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

Phase 3
Study Type
Intervention Model
Parallel Assignment
Primary Purpose
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Sodium Oxybate
Placebo Comparator
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.
  • Drug: Placebo

More Details


Study Contact


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.