Conditions: Narcolepsy
Keywords: Narcolepsy Daytime Sleepiness Daytime sleepiness in narcolepsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 231
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Xyrem + Modafinil Placebo arm 2: Xyrem Placebo + Modafinil Placebo arm 3: Xyrem Placebo + Modafinil at established dose arm 4: Xyrem + Modafinil at established dose

Interventions: intervention 1: Xyrem intervention 2: Xyrem Placebo intervention 3: Modafinil at established dose intervention 4: Modafinil (Placebo)
Intervention descriptions: intervention 1: Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks. intervention 2: Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks. intervention 3: Modafinil oral capsules at 200 to 600 mg per day for 8 weeks. intervention 4: Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.

Protocol document: