NCT00066170

Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

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 Treatment of Daytime Sleepiness in Narcolepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	Xyrem	Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
DRUG	Xyrem Placebo	Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
DRUG	Modafinil at established dose	Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
DRUG	Modafinil (Placebo)	Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.

Timeline

• Start date: 2003-04-01
• Primary completion: 2004-07-01
• Completion: 2004-11-01
• First posted: 2003-08-06
• Last updated: 2011-12-29
• Results posted: 2011-11-30

Locations

40 sites across 4 countries: United States, France, Germany, Switzerland