Status and phase
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About
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
INCLUSION CRITERIA
Patients will be included in the trial if they:
EXCLUSION CRITERIA
Patients will be excluded from the trial if they:
Primary purpose
Allocation
Interventional model
Masking
231 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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