Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
NCT ID: NCT00066170
Last Updated: 2011-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
231 participants
INTERVENTIONAL
2003-04-30
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1.
Xyrem + Modafinil Placebo
Xyrem
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Modafinil (Placebo)
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Group 2:
Xyrem Placebo + Modafinil Placebo
Xyrem Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Modafinil (Placebo)
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Group 3
Xyrem Placebo + Modafinil at established dose
Xyrem Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Modafinil at established dose
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Group 4:
Xyrem + Modafinil at established dose
Xyrem
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Modafinil at established dose
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Interventions
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Xyrem
Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks.
Xyrem Placebo
Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks.
Modafinil at established dose
Modafinil oral capsules at 200 to 600 mg per day for 8 weeks.
Modafinil (Placebo)
Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have signed and dated an informed consent prior to beginning protocol required procedures.
* Are willing and able to complete the entire trial as described in the protocol.
* Are 18 years of age or older.
* Fulfill the International Classification of Sleep Disorders criteria for the diagnosis of narcolepsy.
* Are taking stable doses of modafinil (200 to 600 mg/day) for the treatment of daytime sleepiness for a period of three months or greater and the modafinil dose has been stable for at least 1 month prior to entering this trial
* Females may be included who are surgically sterile, two years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial.
* In the opinion of the investigator have adequate support for the duration of the trial to include transportation to and from the trial site. In addition, if in the investigator's assessment it is clinically indicated, the patient is willing to not operate a car or heavy machinery for the duration of the trial or for as long as the investigator deems clinically indicated.
Exclusion Criteria
* Have received gamma-hydroxybutyrate in the last 30 days.
* Have taken any investigational therapy within the 30-day period prior to the initial screening visit (Visit 1) for this trial.
* Have sleep apnea syndrome, defined as an Apnea Index \> 10 per hour or an AHI (Apnea Hypopnea Index) greater than 15 per hour, or have any other cause of daytime sleepiness, and have any other disorder(s) that can be considered a primary cause of excessive daytime sleepiness (e.g., severe periodic leg movement syndrome as determined by the investigator, sleep apnea, sleep deprivation).
* Are taking hypnotics, tranquilizers, antihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the start of the baseline period. Patients taking anticonvulsants are not eligible to participate event if they are willing to washout anticonvulsants for the trial.
* Are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol.
* Have psychiatric disorders, major affective or psychotic disorders, or other problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms.
* Have a current or recent (within one year) history of a substance use disorder including alcohol abuse as defined by the DSM-IV.
* Have a serum creatinine greater than 2.0 mg/dL, abnormal liver function tests (SGOT \[AST\] or SGPT \[ALT\] more than twice the upper limit of normal), or elevated serum bilirubin (more than 1.5 times the upper limit of normal), or pre-trial ECG results demonstrating clinically significant arrhythmias, greater than a first degree AV block or a history of myocardial infarction within the last six months.
* Have an occupation that requires variable shift work or routine night shift.
* Have a clinically significant history of seizure disorder either past or present, a history of clinically significant head trauma (i.e., concussion resulting in clinically significant loss of consciousness) or past invasive intracranial surgery, and are taking anticonvulsant medications.
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Jazz Pharmaceuticals, Inc.
Principal Investigators
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Yanping Zheng, MD
Role: STUDY_DIRECTOR
Jazz Pharmaceuticals, Inc
Locations
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Pulmonary Associates, PA
Phoenix, Arizona, United States
St. Jude Medical Center -- Sleep Disorders Institute
Fullerton, California, United States
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, United States
Neuro-Therapeutics, Inc.
Pasadena, California, United States
Pacific Sleep Medicine Services, Inc.
San Diego, California, United States
Stanford Sleep Disorders Clinic
Stanford, California, United States
Clinical Research Group of St. Petersburg, Inc.
St. Petersburg, Florida, United States
Peoria Pulmonary Associates, Ltd
Peoria, Illinois, United States
The Center for Sleep and Wake Disorders/Midwest Neurology
Danville, Indiana, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
Community Research & Sleep Management Institute
Crestview Hills, Kentucky, United States
Chest Medicine Associates DBA -- Sleep Medicine Specialists
Louisville, Kentucky, United States
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, United States
Sleep Disorders Center -- Union Hospital of Cecil County
Elkton, Maryland, United States
Sleep Medicine Associates of Maryland
Towson, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University Sleep Center
St Louis, Missouri, United States
New Jersey Neuroscience Institute at JFK Medical Center
Edison, New Jersey, United States
Sleep Disorders Center of Rochester
Rochester, New York, United States
Strong Sleep Disorders Center
Rochester, New York, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder
Winston-Salem, North Carolina, United States
Cincinnati Clinic & Sleep Management Institute
Cincinnati, Ohio, United States
Community Research Management Associates,Inc.
Cincinnati, Ohio, United States
CSC Research -- Grove City Sleep Diagnostic Center
Grove City, Ohio, United States
Lehigh Valley Hospital Sleep Disorders Center
Allentown, Pennsylvania, United States
Capital Region Sleep Disorder Center
Carlisle, Pennsylvania, United States
Center for Sleep Medicine
Lafayette Hill, Pennsylvania, United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, United States
SleepMed of South Carolina
Columbia, South Carolina, United States
SDHRF Clinical Research Center
Sioux Falls, South Dakota, United States
Sioux Valley Clinic -- Pulmonary
Sioux Falls, South Dakota, United States
Sleep Disorders Center
Sioux Falls, South Dakota, United States
Bhupesh Dihenia, MD
Lubbock, Texas, United States
SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd.
San Antonio, Texas, United States
Vermont Medical Sleep Disorders Center, Inc.
Essex Junction, Vermont, United States
Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil
Paris, Cedex 13, France
Centre du sommeil -- Hopital Gui de Chauliac
Montpellier, Cedex 5, France
Psychiatrische Universitatsklinik
Regensburg, , Germany
Neurologische Poliklinik -- Universitats Spital Zurich
Zurich, , Switzerland
Countries
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References
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A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.
Scrima L, Hartman PG, Johnson FH Jr, Thomas EE, Hiller FC. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep. 1990 Dec;13(6):479-90. doi: 10.1093/sleep/13.6.479.
Lammers GJ, Arends J, Declerck AC, Ferrari MD, Schouwink G, Troost J. Gammahydroxybutyrate and narcolepsy: a double-blind placebo-controlled study. Sleep. 1993 Apr;16(3):216-20. doi: 10.1093/sleep/16.3.216.
A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.
Black J, Houghton WC. Sodium oxybate improves excessive daytime sleepiness in narcolepsy. Sleep. 2006 Jul;29(7):939-46. doi: 10.1093/sleep/29.7.939.
Black J, Pardi D, Hornfeldt CS, Inhaber N. The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption: a double-blind, placebo-controlled study in patients with narcolepsy. J Clin Sleep Med. 2010 Dec 15;6(6):596-602.
Husain AM, Bujanover S, Ryan R, Scheckner B, Black J, Profant J. Incidence and duration of common, early-onset adverse events occurring during 2 randomized, placebo-controlled, phase 3 studies of sodium oxybate in participants with narcolepsy. J Clin Sleep Med. 2020 Sep 15;16(9):1469-1474. doi: 10.5664/jcsm.8530.
Dauvilliers Y, Roth T, Guinta D, Alvarez-Horine S, Dynin E, Black J. Effect of sodium oxybate, modafinil, and their combination on disrupted nighttime sleep in narcolepsy. Sleep Med. 2017 Dec;40:53-57. doi: 10.1016/j.sleep.2017.07.030. Epub 2017 Oct 7.
Related Links
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Xyrem Informational website with the package insert
Other Identifiers
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OMC-SXB-22
Identifier Type: -
Identifier Source: org_study_id