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| Sponsor: | Jazz Pharmaceuticals |
|---|---|
| Information provided by: | Jazz Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00066170 |
Purpose
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 |
|---|---|---|
|
Narcolepsy |
Drug: Xyrem Drug: Xyrem Placebo Drug: Modafinil at established dose Drug: Modafinil (Placebo) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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: | 231 |
| 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 |
|---|---|
|
Experimental: Group 1.
Xyrem + Modafinil Placebo
|
Drug: Xyrem
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Other Name: Sodium Oxybate
Drug: Modafinil (Placebo)
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Other Name: Provigil Placebo
|
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Placebo Comparator: Group 2:
Xyrem Placebo + Modafinil Placebo
|
Drug: Xyrem Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Other Name: Sodium Oxybate Placebo
Drug: Modafinil (Placebo)
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Other Name: Provigil Placebo
|
|
Active Comparator: Group 3
Xyrem Placebo + Modafinil at established dose
|
Drug: Xyrem Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Other Name: Sodium Oxybate Placebo
Drug: Modafinil at established dose
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Other Name: Provigil
|
|
Experimental: Group 4:
Xyrem + Modafinil at established dose
|
Drug: Xyrem
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Other Name: Sodium Oxybate
Drug: Modafinil at established dose
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Other Name: Provigil
|
Eligibility| 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:
Contacts and Locations
Show 40 Study Locations| Study Director: | Yanping Zheng, MD | Jazz Pharmaceuticals, Inc |
More Information
| Responsible Party: | Senior Director Clinical Development, Jazz Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00066170 History of Changes |
| Other Study ID Numbers: | OMC-SXB-22 |
| Study First Received: | August 4, 2003 |
| Results First Received: | October 21, 2011 |
| Last Updated: | December 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Narcolepsy Daytime Sleepiness Daytime sleepiness in narcolepsy |
|
Narcolepsy Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Sodium Oxybate Modafinil Adjuvants, Anesthesia Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Stimulants Neuroprotective Agents Protective Agents |