Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
Information source: Orphan Medical
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Narcolepsy
Intervention: Xyrem + Modafinil Placebo (Drug); Xyrem Placebo + Modafinil Placebo (Drug); Xyrem Placebo + Modafinil at established dose (Drug); Xyrem + Modafinil at established dose (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Orphan Medical Official(s) and/or principal investigator(s):
Yanping Zheng, MD, Study Director, Affiliation: Jazz Pharmaceuticals, Inc
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Daytime sleepiness as measured by objective response in the Maintenance of Wakefulness Test (MWT).
Secondary outcome: Change in the overall severity of the patients narcolepsy symptoms as assessed by the investigator using the Clinical Global Impression of Change (CGI-c).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
INCLUSION CRITERIA
Patients will be included in the trial if they:
- 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
Patients will be excluded from the trial if they:
- 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.
Locations and Contacts
Psychiatrische Universitatsklinik, Regensburg 93042, Germany
Neurologische Poliklinik -- Universitats Spital Zurich, Zurich CH-8091, Switzerland
Pulmonary Associates, PA, Phoenix, Arizona 85006, United States
Pacific Sleep Medicine Services, Inc., San Diego, California 92121, United States
St. Jude Medical Center -- Sleep Disorders Institute, Fullerton, California 92835, United States
Pacific Sleep Medicine Services, Inc., Los Angeles, California 90048, United States
Neuro-Therapeutics, Inc., Pasadena, California 91105, United States
Stanford Sleep Disorders Clinic, Stanford, California 94305, United States
Hopital Pitie Salpetriere -- Federation des Pathologies du sommeil, Paris, Cedex 13 75651, France
Centre du sommeil -- Hopital Gui de Chauliac, Montpellier, Cedex 5 34295, France
Clinical Research Group of St. Petersburg, Inc., St. Petersburg, Florida 33707, United States
Peoria Pulmonary Associates, Ltd, Peoria, Illinois 61603, United States
The Center for Sleep and Wake Disorders/Midwest Neurology, Danville, Indiana 46122, United States
Chest Medicine Associates DBA -- Sleep Medicine Specialists, Louisville, Kentucky 40217, United States
Community Research & Sleep Management Institute, Crestview Hills, Kentucky 41017, United States
Graves Gilbert Clinic, Bowling Green, Kentucky 42101, United States
The Center for Sleep & Wake Disorders, Chevy Chase, Maryland 20815, United States
Sleep Medicine Associates of Maryland, Towson, Maryland 21204, United States
Sleep Disorders Center -- Union Hospital of Cecil County, Elkton, Maryland 21921, United States
Henry Ford Hospital, Detroit, Michigan 48202, United States
Washington University Sleep Center, St Louis, Missouri 63108, United States
New Jersey Neuroscience Institute at JFK Medical Center, Edison, New Jersey 08818, United States
Strong Sleep Disorders Center, Rochester, New York 14618, United States
Sleep Disorders Center of Rochester, Rochester, New York 14618, United States
Raleigh Neurology Associates, Raleigh, North Carolina 27607, United States
ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder, Winston-Salem, North Carolina 27103, United States
Community Research Management Associates,Inc., Cincinnati, Ohio 45219, United States
Cincinnati Clinic & Sleep Management Institute, Cincinnati, Ohio 45219, United States
CSC Research -- Grove City Sleep Diagnostic Center, Grove City, Ohio 43123, United States
Center for Sleep Medicine, Lafayette Hill, Pennsylvania 19444, United States
Lehigh Valley Hospital Sleep Disorders Center, Allentown, Pennsylvania 18105, United States
Capital Region Sleep Disorder Center, Carlisle, Pennsylvania 17013, United States
SleepMed of South Carolina, Columbia, South Carolina 29220, United States
Lowcountry Lung and Critical Care, PA, Charleston, South Carolina 29406-7108, United States
SDHRF Clinical Research Center, Sioux Falls, South Dakota 57104, United States
Sioux Valley Clinic -- Pulmonary, Sioux Falls, South Dakota 57105, United States
Sleep Disorders Center, Sioux Falls, South Dakota 57105, United States
SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd., San Antonio, Texas 78229, United States
Bhupesh Dihenia, MD, Lubbock, Texas 79410, United States
Vermont Medical Sleep Disorders Center, Inc., Essex Junction, Vermont 05452, United States
Additional Information
Xyrem Informational website with the package insert Trial results
Related publications: [No authors listed] 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. 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. [No authors listed] 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.
Starting date: April 2003
Ending date: November 2004
Last updated: May 22, 2008
|
