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)
Sleep Disorders Center of Alabama, Inc.
🇺🇸Birmingham, Alabama, United States
Pacific Sleep Medicine Services
🇺🇸La Jolla, California, United States
Stanford Sleep Disorders Clinic
🇺🇸Stanford, California, United States
St. Petersburg Sleep Disorders Center
🇺🇸St. Petersburg, Florida, United States
Sleep Disorders Center of Georgia
🇺🇸Atlanta, Georgia, United States
Sleep Disorders Center--Division of Neurology
🇺🇸Evanston, Illinois, United States
Peoria Pulmonary Associates, Ltd.
🇺🇸Peoria, Illinois, United States
The Center for Sleep and Wake Disorders/Midwest Neurology
🇺🇸Danville, Indiana, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Chest Medicine Associates DBA/Sleep Medicine Specialists
🇺🇸Louisville, Kentucky, United States
Scroll for more (33 remaining)Sleep Disorders Center of Alabama, Inc.🇺🇸Birmingham, Alabama, United States