Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
Information source: Orphan Medical
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Narcolepsy
Intervention: sodium oxybate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Orphan Medical Official(s) and/or principal investigator(s): William Houghton, MD, Study Chair, Affiliation: Orphan Medical Harry N Cook, MBA, RPh, Study Director, Affiliation: Orphan Medical
Summary
The initial portion of the protocol involves discontinuing any medications for cataplexy
that the patient may be taking. Subsequently, the patient is prescribed a dose of oral
solution of study drug or placebo over a 10-11 week period. During the trial, narcolepsy
symptoms will be evaluated. Participants are allowed to continue using stimulant
medications at constant doses during the study. A total of 1 to 3 daytime visits in
addition to 4 overnight visits to the sleep center will be required to complete the study.
Clinical Details
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) With Placebo for the Treatment of Narcolepsy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
INCLUSION CRITERIA
- Have signed & dated informed consent before beginning protocol procedures.
- Willing & able to complete entire trial as described in protocol.
- 16 years of age or older.
- Have a history and presenting symptoms of excessive daytime sleepiness.
- Have a history of cataplexy localizable to a specific muscle group(s) or part(s) of
body during which the patient is lucid (not experiencing an inadvertent nap or micro
sleep).
- Have valid PSG & MSLT scores (collected during an overnight test) within last five
years and a current diagnosis of narcolepsy according to the following criteria
established by the American Sleep Disorders Association: (1) Recurrent daytime naps
or lapses into sleep occur almost daily for at least 3 months; (2) Sudden bilateral
loss of postural muscle tone occurs in association with intense emotion (cataplexy);
(3) Polysomnography demonstrates one or more of the following: (a) Sleep latency less
than 10 minutes; (b) REM sleep latency less than 20 minutes; (c) An MSLT that
demonstrates a mean sleep latency of less than 5 minutes; (d) Two or more sleep-onset
REM periods
- Females who are surgically sterile, two years post-menopausal, or if of child-bearing
potential, using a medically accepted method of birth control 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 trial
to include transportation to and from 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
- Received gamma-hydroxybutyrate in the last 30 days.
- Have taken any investigational therapy within 30-day period prior to initial
screening visit for this trial.
- Patients taking fluoxetine (Prozac).
- Have been diagnosed with sleep apnea syndrome, defined as an Apnea Index > 10 per
hour or an 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.
- 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 even if willing to
washout anticonvulsants for the trial.
- Experiencing unstable cardiovascular, endocrine, neoplastic (excluding localized
basal cell carcinoma), 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
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 current or recent (within one year) history of a substance use disorder
including alcohol abuse as defined by DSM-IV.
- 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 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 last six months.
- Have an occupation that requires variable shift work or routine night shift.
- Have a clinically significant history of seizure disorder, 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
Neurologische Poliklinik - Universitats Spital Zurich, Zurich CH-8091, Switzerland
Sleep Disorders Center of Alabama, Inc., Birmingham, Alabama 35213, United States
Canadian Sleep Institute, Calgary, Alberta T2X2A8, Canada
Vancouver Hospital -- Sleep Disorders Clinic, Vancouver, British Columbia V6T2B5, Canada
Pacific Sleep Medicine Services, La Jolla, California 92037-1205, United States
Stanford Sleep Disorders Clinic, Stanford, California 94305, United States
St. Petersburg Sleep Disorders Center, St. Petersburg, Florida 33707, United States
Sleep Disorders Center of Georgia, Atlanta, Georgia 30342, United States
Sleep Disorders Center--Division of Neurology, Evanston, Illinois 60201, 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
Fort Wayne Neurological Center, Fort Wayne, Indiana 46804, United States
Fort Wayne Neurological Center, Fort Wayne, Indiana 46805, United States
Chest Medicine Associates DBA/Sleep Medicine Specialists, Louisville, Kentucky 40217, United States
LSU Health Science Center, Shreveport, Louisiana 71130, United States
Center for Sleep and Wake Disorders, Chevy Chase, Maryland 20815, United States
Center for Sleep Diagnostics, Newton, Massachusetts 02459, United States
Department of Neurology, Worcester, Massachusetts 01608, United States
Washington University -- Sleep Medicine Center, Saint Louis, Missouri 63108, United States
Saint John Regional Hospital -- Somnology Program, Saint John, New Brunswick E2L4L2, Canada
Sleep/Wake Center 7N2 -- Bellevue Hospital Center, New York, New York 10016, United States
The Sleep Center - Community General Hospital, Syracuse, New York 13215, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Raleigh Neurology Associates, Raleigh, North Carolina 27607, United States
Central Carolina Neurology & Sleep, Salisbury, North Carolina 28144, United States
CSC Research -- Grove City Sleep Diagnostic Center, Grove City, Ohio 43123, United States
Southwest Cleveland Sleep Center, Middleburg Heights, Ohio 44130, United States
Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States
Clinical Pharmaceutical Trials, Inc., Tulsa, Oklahoma 74104, United States
The Ottawa Hospital Sleep Centre -- Ottawa Hospital -- Civic Campus -- Sleep Laboratory, Ottawa, Ontario K1Y 4E9, Canada
Brain & Sleep Diagnostic Center, Toronto, Ontario M8X2W2, Canada
The Sleep Disorders Clinic of the Centre for Sleep and Chronobiology, Toronto, Ontario M5T 3A9, Canada
Sleep Disorder Centre -- Hopital du Sacre-Coeur, Montreal, Quebec H4J1C5, Canada
Miriam Hospital, Providence, Rhode Island 02906, United States
Rhode Island Hospital - Division of Pulmonary, Sleep and Critical Care Medicine, Providence, Rhode Island 02903, United States
Charleston Pulmonary Associates PA, Charleston, South Carolina 29403, United States
Low Country Lung and Critical Care PA, Charleston, South Carolina 29406-7108, United States
Palmetto Baptist Medical Center Sleep Disorders Center, Columbia, South Carolina 29201, United States
Charleston Pulmonary Associates PA, Mount Pleasant, South Carolina 29464, United States
Sleep Medicine Assoc PLLC -- Summit Medical Center, Hermitage, Tennessee 37076, United States
The Houston Sleep Center, Houston, Texas 77024, United States
Sleep Medicine Associates of Texas, Plano, Texas 75093, United States
Sleep Disorders Center -- Eastern Virginia Medical School -- Sentara General Hospital, Norfolk, Virginia 23507, United States
VCU Health System MCV Hospitals - Sleep Disorders Center, Richmond, Virginia 23235, United States
Swedish Sleep Medicine Institute, Seattle, Washington 98122, United States
Additional Information
Related publications: 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. 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: December 2000
Last updated: June 23, 2005
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