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

Phase 3

Completed

• Conditions: Narcolepsy
• Interventions: Drug: Xyrem; Drug: Xyrem Placebo; Drug: Modafinil (Placebo); Drug: Modafinil at established dose

• Registration Number: NCT00066170
• Lead Sponsor: Jazz Pharmaceuticals

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

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-08-04
• Study First Submitted QC: 2003-08-05
• Study First Posted: 2003-08-06
• Primary Completion: 2004-07
• Study Completion: 2004-11
• Results First Submitted: 2011-10-21
• Results First Submitted QC: 2011-10-21
• Results First Posted: 2011-11-30
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4:	Xyrem	Xyrem + Modafinil at established dose
Group 1.	Modafinil (Placebo)	Xyrem + Modafinil Placebo
Group 2:	Modafinil (Placebo)	Xyrem Placebo + Modafinil Placebo
Group 4:	Modafinil at established dose	Xyrem + Modafinil at established dose
Group 1.	Xyrem	Xyrem + Modafinil Placebo
Group 2:	Xyrem Placebo	Xyrem Placebo + Modafinil Placebo
Group 3	Xyrem Placebo	Xyrem Placebo + Modafinil at established dose
Group 3	Modafinil at established dose	Xyrem Placebo + Modafinil at established dose

Primary Outcome Measures

Name	Time	Method
Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)	Baseline to Week 8	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.

Trial Locations

Locations (39)

Pulmonary Associates, PA; 🇺🇸 Phoenix, Arizona, United States

St. Jude Medical Center -- Sleep Disorders Institute; 🇺🇸 Fullerton, California, United States

Pacific Sleep Medicine Services, Inc.; 🇺🇸 San Diego, California, United States

Neuro-Therapeutics, Inc.; 🇺🇸 Pasadena, California, United States

Stanford Sleep Disorders Clinic; 🇺🇸 Stanford, California, United States

Clinical Research Group of St. Petersburg, Inc.; 🇺🇸 St. Petersburg, Florida, United States

Peoria Pulmonary Associates, Ltd; 🇺🇸 Peoria, Illinois, United States

The Center for Sleep and Wake Disorders/Midwest Neurology; 🇺🇸 Danville, Indiana, United States

Graves Gilbert Clinic; 🇺🇸 Bowling Green, Kentucky, United States

Community Research & Sleep Management Institute; 🇺🇸 Crestview Hills, Kentucky, United States

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