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

  • STATUS
    Recruiting
Updated on 22 February 2019
stimulant
sodium oxybate
excessive daytime sleepiness
cataplexy

Summary

The purpose of this study is to determine whether Sodium Oxybate is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

 

Details
Condition Narcolepsy, *Healthy Children Studies
Clinical Study IdentifierTX218032
Last Modified on22 February 2019

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
Exclusion criteria

Exclusion Criteria

Previous dosing must have been limited to no more than 4.5g per night
Patient should not have taken sodium oxybate for more than 2 weeks
All previous dosing must not have occurred within the last year prior to entry to the study
Current use of sodium valproate
Any use of the following prohibited medications for the duration of the clinical study
Anticonvulsants
Clonidine
SSRIs and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
MAOIs
TCAs
Hypnotics Anxiolytics Sedating antihistamines
Antipsychotics Other experimental medications designed to treat narcolepsy, cataplexy or any other condition
Treatment with any investigational products within 3 months before study enrollment
Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
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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