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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
231
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Pulmonary Associates, PA
Phoenix, Arizona, United States
St. Jude Medical Center -- Sleep Disorders Institute
Fullerton, California, United States
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, United States
Neuro-Therapeutics, Inc.
Pasadena, California, United States
Pacific Sleep Medicine Services, Inc.
San Diego, California, United States
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)
The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.
Time frame: Baseline to Week 8
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