Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 31, 2000

Study Completion Date

April 30, 2004

Conditions
Narcolepsy
Interventions
DRUG

sodium oxybate

Trial Locations (45)

10016

Sleep/Wake Center 7N2 -- Bellevue Hospital Center, New York

13215

The Sleep Center - Community General Hospital, Syracuse

20815

Center for Sleep and Wake Disorders, Chevy Chase

23235

VCU Health System MCV Hospitals - Sleep Disorders Center, Richmond

23507

Sleep Disorders Center -- Eastern Virginia Medical School -- Sentara General Hospital, Norfolk

27607

Raleigh Neurology Associates, Raleigh

27710

Duke University Medical Center, Durham

28144

Central Carolina Neurology & Sleep, Salisbury

29201

Palmetto Baptist Medical Center Sleep Disorders Center, Columbia

29403

Charleston Pulmonary Associates PA, Charleston

29464

Charleston Pulmonary Associates PA, Mt. Pleasant

30342

Sleep Disorders Center of Georgia, Atlanta

33707

St. Petersburg Sleep Disorders Center, St. Petersburg

35213

Sleep Disorders Center of Alabama, Inc., Birmingham

37076

Sleep Medicine Assoc PLLC -- Summit Medical Center, Hermitage

40217

Chest Medicine Associates DBA/Sleep Medicine Specialists, Louisville

43123

CSC Research -- Grove City Sleep Diagnostic Center, Grove City

44130

Southwest Cleveland Sleep Center, Middleburg Heights

46122

The Center for Sleep and Wake Disorders/Midwest Neurology, Danville

46804

Fort Wayne Neurological Center, Fort Wayne

46805

Fort Wayne Neurological Center, Fort Wayne

60201

Sleep Disorders Center--Division of Neurology, Evanston

61603

Peoria Pulmonary Associates, Ltd., Peoria

63108

Washington University -- Sleep Medicine Center, St Louis

71130

LSU Health Science Center, Shreveport

73112

Lynn Health Science Institute, Oklahoma City

74104

Clinical Pharmaceutical Trials, Inc., Tulsa

75093

Sleep Medicine Associates of Texas, Plano

77024

The Houston Sleep Center, Houston

94305

Stanford Sleep Disorders Clinic, Stanford

98122

Swedish Sleep Medicine Institute, Seattle

92037-1205

Pacific Sleep Medicine Services, La Jolla

02459

Center for Sleep Diagnostics, Newton

01608

Department of Neurology, Worcester

02903

Rhode Island Hospital - Division of Pulmonary, Sleep and Critical Care Medicine, Providence

02906

Miriam Hospital, Providence

29406-7108

Low Country Lung and Critical Care PA, Charleston

T2X2A8

Canadian Sleep Institute, Calgary

V6T2B5

Vancouver Hospital -- Sleep Disorders Clinic, Vancouver

E2L4L2

Saint John Regional Hospital -- Somnology Program, Saint John

K1Y 4E9

The Ottawa Hospital Sleep Centre -- Ottawa Hospital -- Civic Campus -- Sleep Laboratory, Ottawa

M5T 3A9

The Sleep Disorders Clinic of the Centre for Sleep and Chronobiology, Toronto

M8X2W2

Brain & Sleep Diagnostic Center, Toronto

H4J1C5

Sleep Disorder Centre -- Hopital du Sacre-Coeur, Montreal

CH-8091

Neurologische Poliklinik - Universitats Spital Zurich, Zurich

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Orphan Medical

INDUSTRY

NCT00049803 - Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients | Biotech Hunter | Biotech Hunter