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Sponsored by: |
Orphan Medical |
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Information provided by: | Orphan Medical |
ClinicalTrials.gov Identifier: | NCT00066170 |
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.
Condition | Intervention | Phase |
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Narcolepsy |
Drug: Xyrem + Modafinil Placebo Drug: Xyrem Placebo + Modafinil Placebo Drug: Xyrem Placebo + Modafinil at established dose Drug: Xyrem + Modafinil at established dose |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy |
Enrollment: | 278 |
Study Start Date: | April 2003 |
Study Completion Date: | November 2004 |
Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1.: Experimental
Xyrem + Modafinil Placebo
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Drug: Xyrem + Modafinil Placebo
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks + Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
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Group 2:: Placebo Comparator
Xyrem Placebo + Modafinil Placebo
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Drug: Xyrem Placebo + Modafinil Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks. Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
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Group 3: Active Comparator
Xyrem Placebo + Modafinil at established dose
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Drug: Xyrem Placebo + Modafinil at established dose
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks. Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
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Group 4:: Experimental
Xyrem + Modafinil at established dose
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Drug: Xyrem + Modafinil at established dose
Xyrem oral solution 6 g per day for 4 weeks and 9 g per day for another 4 weeks. Modafinil oral capsules 200 to 600 mg per day for 8 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
Patients will be included in the trial if they:
EXCLUSION CRITERIA
Patients will be excluded from the trial if they:
Study Director: | Yanping Zheng, MD | Jazz Pharmaceuticals, Inc |
Responsible Party: | Jazz Pharmaceuticals, Inc. ( Senior Director Clinical Development ) |
Study ID Numbers: | OMC-SXB-22 |
Study First Received: | August 4, 2003 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00066170 |
Health Authority: | United States: Food and Drug Administration |
Narcolepsy Daytime Sleepiness Daytime sleepiness in narcolepsy |
Mental Disorders Narcolepsy Dyssomnias Sleep Disorders Disorders of Excessive Somnolence |
Modafinil Sodium Oxybate Gelineau's syndrome Sleep Disorders, Intrinsic |
Anesthetics, Intravenous Nervous System Diseases Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Central Nervous System Stimulants Neuroprotective Agents |
Protective Agents Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Therapeutic Uses Central Nervous System Agents |