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

  • STATUS
    Recruiting
  • participants needed
    264
  • sponsor
    Flamel Ireland Limited
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Updated on 10 July 2018
See if I qualify
stimulant
sleep disorder
sodium oxybate
somnolence
excessive daytime sleepiness
cataplexy
multiple sleep latency test

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.

Details
Condition Cataplexy, Narcolepsy, Excessive Daytime Sleepiness
Treatment Placebo, Sodium Oxybate
Clinical Study IdentifierNCT02720744
SponsorFlamel Ireland Limited
Last Modified on10 July 2018

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female subjects 16 years of age or older
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
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
Current continuing presence of EDS as defined by subject report for the last 3 months and an ESS > 10
For NT1 only, current continuing presence of cataplexy as defined by subject report for the last 3 months
Subjects may use concomitant stimulants, but must comply with the following
They must be on a stable dose of stimulants for at least 3 weeks prior to starting the screening process for this study; AND
They must use the same stimulant regimen throughout the entire study period, including during screening and posttreatment periods
They must discontinue all anti cataplexy drugs
Addition inclusion criteria per protocol
Additional

Exclusion Criteria

Additional exclusion criteria per protocol
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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