Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
- Conditions
- Narcolepsy
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
Not provided
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
The Center for Sleep and Wake Disorders/Midwest Neurology
🇺🇸Danville, Indiana, United States
Clinical Research Group of St. Petersburg, Inc.
🇺🇸St. Petersburg, Florida, United States
Psychiatrische Universitatsklinik
🇩🇪Regensburg, Germany
Neurologische Poliklinik -- Universitats Spital Zurich
🇨ðŸ‡Zurich, Switzerland
Stanford Sleep Disorders Clinic
🇺🇸Stanford, California, United States
ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder
🇺🇸Winston-Salem, North Carolina, United States
CSC Research -- Grove City Sleep Diagnostic Center
🇺🇸Grove City, Ohio, United States
Pulmonary Associates, PA
🇺🇸Phoenix, Arizona, United States
Pacific Sleep Medicine Services, Inc.
🇺🇸San Diego, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Cincinnati Clinic & Sleep Management Institute
🇺🇸Cincinnati, Ohio, United States
Community Research Management Associates,Inc.
🇺🇸Cincinnati, Ohio, United States
SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd.
🇺🇸San Antonio, Texas, United States
St. Jude Medical Center -- Sleep Disorders Institute
🇺🇸Fullerton, California, United States
Neuro-Therapeutics, Inc.
🇺🇸Pasadena, California, United States
Community Research & Sleep Management Institute
🇺🇸Crestview Hills, Kentucky, United States
Peoria Pulmonary Associates, Ltd
🇺🇸Peoria, Illinois, United States
Graves Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
The Center for Sleep & Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Sleep Disorders Center -- Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
Chest Medicine Associates DBA -- Sleep Medicine Specialists
🇺🇸Louisville, Kentucky, United States
New Jersey Neuroscience Institute at JFK Medical Center
🇺🇸Edison, New Jersey, United States
Washington University Sleep Center
🇺🇸St Louis, Missouri, United States
Sleep Medicine Associates of Maryland
🇺🇸Towson, Maryland, United States
Sleep Disorders Center of Rochester
🇺🇸Rochester, New York, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Capital Region Sleep Disorder Center
🇺🇸Carlisle, Pennsylvania, United States
Strong Sleep Disorders Center
🇺🇸Rochester, New York, United States
Lowcountry Lung and Critical Care, PA
🇺🇸Charleston, South Carolina, United States
Lehigh Valley Hospital Sleep Disorders Center
🇺🇸Allentown, Pennsylvania, United States
SDHRF Clinical Research Center
🇺🇸Sioux Falls, South Dakota, United States
SleepMed of South Carolina
🇺🇸Columbia, South Carolina, United States
Center for Sleep Medicine
🇺🇸Lafayette Hill, Pennsylvania, United States
Sioux Valley Clinic -- Pulmonary
🇺🇸Sioux Falls, South Dakota, United States
Sleep Disorders Center
🇺🇸Sioux Falls, South Dakota, United States
Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil
🇫🇷Paris, Cedex 13, France
Bhupesh Dihenia, MD
🇺🇸Lubbock, Texas, United States
Vermont Medical Sleep Disorders Center, Inc.
🇺🇸Essex Junction, Vermont, United States
Centre du sommeil -- Hopital Gui de Chauliac
🇫🇷Montpellier, Cedex 5, France