Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
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:
  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
  2. Current use of sodium valproate
  3. Any use of the following prohibited medications for the duration of the clinical study:
  4. Anticonvulsants
  5. Clonidine
  6. SSRIs and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
  7. MAOIs
  8. TCAs
  9. Hypnotics
  10. Anxiolytics
  11. Sedating antihistamines
  12. Antipsychotics
  13. Other experimental medications designed to treat narcolepsy, cataplexy or any other condition
  14. Treatment with any investigational products within 3 months before study enrollment
  15. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
  16. Additional exclusion criteria per protocol

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Montefiore Sleep-Wake Disorders Center
Bronx, New York 10467
Contact:
Michael J Thorpy
718-920-2880
michael.thorpy@einstein.yu.edu

More Details

NCT ID
NCT02720744
Status
Recruiting
Sponsor
Flamel Ireland Limited

Study Contact

Siobhan O'Daly
+353 1 4851210
clinicaltrials@flamel.com

Notice

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.