Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
Participant gender:
Summary
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.