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| Sponsor: | Orphan Medical |
|---|---|
| Information provided by: | Orphan Medical |
| 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 + 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 |
|---|---|
|
Group 1.: Experimental
Xyrem + Modafinil Placebo
|
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.
|
|
Group 2:: Placebo Comparator
Xyrem Placebo + Modafinil Placebo
|
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.
|
|
Group 3: Active Comparator
Xyrem Placebo + Modafinil at established dose
|
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.
|
|
Group 4:: Experimental
Xyrem + Modafinil at established dose
|
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.
|
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
Hide Study Locations| United States, Arizona | |
| Pulmonary Associates, PA | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Pacific Sleep Medicine Services, Inc. | |
| San Diego, California, United States, 92121 | |
| St. Jude Medical Center -- Sleep Disorders Institute | |
| Fullerton, California, United States, 92835 | |
| Pacific Sleep Medicine Services, Inc. | |
| Los Angeles, California, United States, 90048 | |
| Neuro-Therapeutics, Inc. | |
| Pasadena, California, United States, 91105 | |
| Stanford Sleep Disorders Clinic | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Clinical Research Group of St. Petersburg, Inc. | |
| St. Petersburg, Florida, United States, 33707 | |
| United States, Illinois | |
| Peoria Pulmonary Associates, Ltd | |
| Peoria, Illinois, United States, 61603 | |
| United States, Indiana | |
| The Center for Sleep and Wake Disorders/Midwest Neurology | |
| Danville, Indiana, United States, 46122 | |
| United States, Kentucky | |
| Chest Medicine Associates DBA -- Sleep Medicine Specialists | |
| Louisville, Kentucky, United States, 40217 | |
| Community Research & Sleep Management Institute | |
| Crestview Hills, Kentucky, United States, 41017 | |
| Graves Gilbert Clinic | |
| Bowling Green, Kentucky, United States, 42101 | |
| United States, Maryland | |
| The Center for Sleep & Wake Disorders | |
| Chevy Chase, Maryland, United States, 20815 | |
| Sleep Medicine Associates of Maryland | |
| Towson, Maryland, United States, 21204 | |
| Sleep Disorders Center -- Union Hospital of Cecil County | |
| Elkton, Maryland, United States, 21921 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| Washington University Sleep Center | |
| St Louis, Missouri, United States, 63108 | |
| United States, New Jersey | |
| New Jersey Neuroscience Institute at JFK Medical Center | |
| Edison, New Jersey, United States, 08818 | |
| United States, New York | |
| Strong Sleep Disorders Center | |
| Rochester, New York, United States, 14618 | |
| Sleep Disorders Center of Rochester | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| Raleigh Neurology Associates | |
| Raleigh, North Carolina, United States, 27607 | |
| ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Community Research Management Associates,Inc. | |
| Cincinnati, Ohio, United States, 45219 | |
| Cincinnati Clinic & Sleep Management Institute | |
| Cincinnati, Ohio, United States, 45219 | |
| CSC Research -- Grove City Sleep Diagnostic Center | |
| Grove City, Ohio, United States, 43123 | |
| United States, Pennsylvania | |
| Center for Sleep Medicine | |
| Lafayette Hill, Pennsylvania, United States, 19444 | |
| Lehigh Valley Hospital Sleep Disorders Center | |
| Allentown, Pennsylvania, United States, 18105 | |
| Capital Region Sleep Disorder Center | |
| Carlisle, Pennsylvania, United States, 17013 | |
| United States, South Carolina | |
| SleepMed of South Carolina | |
| Columbia, South Carolina, United States, 29220 | |
| Lowcountry Lung and Critical Care, PA | |
| Charleston, South Carolina, United States, 29406-7108 | |
| United States, South Dakota | |
| SDHRF Clinical Research Center | |
| Sioux Falls, South Dakota, United States, 57104 | |
| Sioux Valley Clinic -- Pulmonary | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sleep Disorders Center | |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Texas | |
| SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd. | |
| San Antonio, Texas, United States, 78229 | |
| Bhupesh Dihenia, MD | |
| Lubbock, Texas, United States, 79410 | |
| United States, Vermont | |
| Vermont Medical Sleep Disorders Center, Inc. | |
| Essex Junction, Vermont, United States, 05452 | |
| France, Cedex 13 | |
| Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil | |
| Paris, Cedex 13, France, 75651 | |
| France, Cedex 5 | |
| Centre du sommeil -- Hopital Gui de Chauliac | |
| Montpellier, Cedex 5, France, 34295 | |
| Germany | |
| Psychiatrische Universitatsklinik | |
| Regensburg, Germany, 93042 | |
| Switzerland | |
| Neurologische Poliklinik -- Universitats Spital Zurich | |
| Zurich, Switzerland, CH-8091 | |
| Study Director: | Yanping Zheng, MD | Jazz Pharmaceuticals, Inc |
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Narcolepsy Daytime Sleepiness Daytime sleepiness in narcolepsy |
|
Anesthetics, Intravenous Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants Anesthetics Dyssomnias Sleep Disorders Central Nervous System Stimulants Disorders of Excessive Somnolence Protective Agents Neuroprotective Agents |
Modafinil Pharmacologic Actions Sleep Disorders, Intrinsic Adjuvants, Anesthesia Anesthetics, General Narcolepsy Mental Disorders Therapeutic Uses Central Nervous System Agents Sodium Oxybate |