Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients - Article
Clinical Trial: Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients
This study has been completed.
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.
|Condition||Treatment or Intervention||Phase|
|Narcolepsy || Drug: sodium oxybate ||Phase III |
MedlinePlus related topics: Sleep Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Expected Total Enrollment: 200
Study start: December 2000; Study completion: April 2004
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both
- 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.
- 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.
Sleep Disorders Center of Alabama, Inc., Birmingham, Alabama, 35213, United States
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
Fort Wayne Neurological Center, Fort Wayne, Indiana, 46804, United States
Fort Wayne Neurological Center, Fort Wayne, Indiana, 46805, 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
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
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
Southwest Cleveland Sleep Center, Middleburg Heights, Ohio, 44130, United States
CSC Research -- Grove City Sleep Diagnostic Center, Grove City, Ohio, 43123, United States
Lynn Health Science Institute, Oklahoma City, Oklahoma, 73112, United States
Clinical Pharmaceutical Trials, Inc., Tulsa, Oklahoma, 74104, United States
Rhode Island Hospital - Division of Pulmonary, Sleep and Critical Care Medicine, Providence, Rhode Island, 02903, United States
Miriam Hospital, Providence, Rhode Island, 02906, United States
Palmetto Baptist Medical Center Sleep Disorders Center, Columbia, South Carolina, 29201, United States
Low Country Lung and Critical Care PA, Charleston, South Carolina, 29406-7108, United States
Charleston Pulmonary Associates PA, Charleston, South Carolina, 29403, 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
Canadian Sleep Institute, Calgary, Alberta, T2X2A8, Canada
Canada, British Columbia
Vancouver Hospital -- Sleep Disorders Clinic, Vancouver, British Columbia, V6T2B5, Canada
Canada, New Brunswick
Saint John Regional Hospital -- Somnology Program, Saint John, New Brunswick, E2L4L2, Canada
Brain & Sleep Diagnostic Center, Toronto, Ontario, M8X2W2, Canada
The Ottawa Hospital Sleep Centre -- Ottawa Hospital -- Civic Campus -- Sleep Laboratory, Ottawa, Ontario, K1Y 4E9, 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
Neurologische Poliklinik - Universitats Spital Zurich, Zurich, CH-8091, Switzerland
William Houghton, MD, Study Chair, Orphan Medical
Harry N Cook, MBA, RPh, Study Director, Orphan Medical
[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.
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: November 13, 2002
ClinicalTrials.gov Identifier: NCT00049803
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
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