231
Participants
Start Date
April 30, 2003
Primary Completion Date
July 31, 2004
Study Completion Date
November 30, 2004
Xyrem
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Xyrem Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Modafinil at established dose
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Modafinil (Placebo)
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Sleep Disorders Center of Rochester, Rochester
Strong Sleep Disorders Center, Rochester
Capital Region Sleep Disorder Center, Carlisle
Lehigh Valley Hospital Sleep Disorders Center, Allentown
Center for Sleep Medicine, Lafayette Hill
The Center for Sleep & Wake Disorders, Chevy Chase
Sleep Medicine Associates of Maryland, Towson
Sleep Disorders Center -- Union Hospital of Cecil County, Elkton
ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder, Winston-Salem
Raleigh Neurology Associates, Raleigh
SleepMed of South Carolina, Columbia
Clinical Research Group of St. Petersburg, Inc., St. Petersburg
Centre du sommeil -- Hopital Gui de Chauliac, Montpellier
Chest Medicine Associates DBA -- Sleep Medicine Specialists, Louisville
Community Research & Sleep Management Institute, Crestview Hills
Graves Gilbert Clinic, Bowling Green
CSC Research -- Grove City Sleep Diagnostic Center, Grove City
Cincinnati Clinic & Sleep Management Institute, Cincinnati
Community Research Management Associates,Inc., Cincinnati
The Center for Sleep and Wake Disorders/Midwest Neurology, Danville
Henry Ford Hospital, Detroit
SDHRF Clinical Research Center, Sioux Falls
Sioux Valley Clinic -- Pulmonary, Sioux Falls
Sleep Disorders Center, Sioux Falls
Peoria Pulmonary Associates, Ltd, Peoria
Washington University Sleep Center, St Louis
Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil, Paris
SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd., San Antonio
Bhupesh Dihenia, MD, Lubbock
Pulmonary Associates, PA, Phoenix
Pacific Sleep Medicine Services, Inc., Los Angeles
Neuro-Therapeutics, Inc., Pasadena
Pacific Sleep Medicine Services, Inc., San Diego
St. Jude Medical Center -- Sleep Disorders Institute, Fullerton
Psychiatrische Universitatsklinik, Regensburg
Stanford Sleep Disorders Clinic, Stanford
New Jersey Neuroscience Institute at JFK Medical Center, Edison
Lowcountry Lung and Critical Care, PA, Charleston
Vermont Medical Sleep Disorders Center, Inc., Essex Junction
Neurologische Poliklinik -- Universitats Spital Zurich, Zurich
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY