Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
- Conditions
- Narcolepsy
- Registration Number
- NCT00049803
- Lead Sponsor
- Orphan Medical
- Brief Summary
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week period. During the trial, narcolepsy symptoms will be evaluated. Participants are allowed to continue using stimulant medications at constant doses during the study. A total of 1 to 3 daytime visits in addition to 4 overnight visits to the sleep center will be required to complete the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
The Sleep Disorders Clinic of the Centre for Sleep and Chronobiology
🇨🇦Toronto, Ontario, Canada
Vancouver Hospital -- Sleep Disorders Clinic
🇨🇦Vancouver, British Columbia, Canada
Sleep Disorders Center of Georgia
🇺🇸Atlanta, Georgia, United States
Pacific Sleep Medicine Services
🇺🇸La Jolla, California, United States
Stanford Sleep Disorders Clinic
🇺🇸Stanford, California, United States
The Center for Sleep and Wake Disorders/Midwest Neurology
🇺🇸Danville, Indiana, United States
Neurologische Poliklinik - Universitats Spital Zurich
🇨🇭Zurich, Switzerland
Sleep Disorders Center -- Eastern Virginia Medical School -- Sentara General Hospital
🇺🇸Norfolk, Virginia, United States
The Sleep Center - Community General Hospital
🇺🇸Syracuse, New York, United States
Canadian Sleep Institute
🇨🇦Calgary, Alberta, Canada
Center for Sleep and Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Washington University -- Sleep Medicine Center
🇺🇸Saint Louis, Missouri, United States
Central Carolina Neurology & Sleep
🇺🇸Salisbury, North Carolina, United States
St. Petersburg Sleep Disorders Center
🇺🇸St. Petersburg, Florida, United States
LSU Health Science Center
🇺🇸Shreveport, Louisiana, United States
Saint John Regional Hospital -- Somnology Program
🇨🇦Saint John, New Brunswick, Canada
Sleep Medicine Assoc PLLC -- Summit Medical Center
🇺🇸Hermitage, Tennessee, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Brain & Sleep Diagnostic Center
🇨🇦Toronto, Ontario, Canada
Charleston Pulmonary Associates PA
🇺🇸Mount Pleasant, South Carolina, United States
Sleep/Wake Center 7N2 -- Bellevue Hospital Center
🇺🇸New York, New York, United States
Center for Sleep Diagnostics
🇺🇸Newton, Massachusetts, United States
Rhode Island Hospital - Division of Pulmonary, Sleep and Critical Care Medicine
🇺🇸Providence, Rhode Island, United States
Department of Neurology
🇺🇸Worcester, Massachusetts, United States
Clinical Pharmaceutical Trials, Inc.
🇺🇸Tulsa, Oklahoma, United States
CSC Research -- Grove City Sleep Diagnostic Center
🇺🇸Grove City, Ohio, United States
Sleep Medicine Associates of Texas
🇺🇸Plano, Texas, United States
Swedish Sleep Medicine Institute
🇺🇸Seattle, Washington, United States
Sleep Disorders Center of Alabama, Inc.
🇺🇸Birmingham, Alabama, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
The Houston Sleep Center
🇺🇸Houston, Texas, United States
Sleep Disorders Center--Division of Neurology
🇺🇸Evanston, Illinois, United States
Peoria Pulmonary Associates, Ltd.
🇺🇸Peoria, Illinois, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Southwest Cleveland Sleep Center
🇺🇸Middleburg Heights, Ohio, United States
Palmetto Baptist Medical Center Sleep Disorders Center
🇺🇸Columbia, South Carolina, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
The Ottawa Hospital Sleep Centre -- Ottawa Hospital -- Civic Campus -- Sleep Laboratory
🇨🇦Ottawa, Ontario, Canada
Sleep Disorder Centre -- Hopital du Sacre-Coeur
🇨🇦Montreal, Quebec, Canada
Low Country Lung and Critical Care PA
🇺🇸Charleston, South Carolina, United States
Chest Medicine Associates DBA/Sleep Medicine Specialists
🇺🇸Louisville, Kentucky, United States
VCU Health System MCV Hospitals - Sleep Disorders Center
🇺🇸Richmond, Virginia, United States