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Sponsored by: |
Orphan Medical |
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Information provided by: | Orphan Medical |
ClinicalTrials.gov Identifier: | NCT00049803 |
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.
Condition | Intervention | Phase |
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Narcolepsy |
Drug: sodium oxybate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) With Placebo for the Treatment of Narcolepsy |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
EXCLUSION CRITERIA
Study Chair: | William Houghton, MD | Orphan Medical |
Study Director: | Harry N Cook, MBA, RPh | Orphan Medical |
Study ID Numbers: | OMC-SXB-15 |
Study First Received: | November 13, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00049803 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Narcolepsy Sodium Oxybate Cataplexy Excessive Daytime Sleepiness |
GHB Gamma Hydroxybutyric Acid Orphan Medical Orphan Drug |
Anesthetics, Intravenous Adjuvants, Immunologic Central Nervous System Depressants Sleep Disorders Dyssomnias Anesthetics Disorders of Excessive Somnolence |
Sleep Disorders, Intrinsic Cataplexy Narcolepsy Mental Disorders Anesthetics, General Gelineau's Syndrome Sodium Oxybate |
Anesthetics, Intravenous Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants Anesthetics Dyssomnias Sleep Disorders Disorders of Excessive Somnolence Pharmacologic Actions |
Sleep Disorders, Intrinsic Adjuvants, Anesthesia Anesthetics, General Narcolepsy Mental Disorders Therapeutic Uses Central Nervous System Agents Sodium Oxybate |