Clinical Trial: Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatme
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 Summary:
Sponsor: Jazz Pharmaceuticals
Current Primary Outcome: Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT) [ Time Frame: Baseline to Week 8 ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Jazz Pharmaceuticals
Dates:
Date Received: August 4, 2003
Date Started: April 2003
Date Completion:
Last Updated: December 21, 2011
Last Verified: December 2011