Clinical Trial: Safety and efficacy of Xyrem oral solution (sodium oxybate) compared with placebo in narcoleptic patients

This study has been completed.

Sponsored by: Orphan Medical
Information provided by: Orphan Medical

Purpose

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

Further Study Details: 

Expected Total Enrollment:  200

Study start: December 2000;  Study completion: April 2004

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  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.

Location Information


Alabama
      Sleep Disorders Center of Alabama, Inc., Birmingham,  Alabama,  35213,  United States

California
      Pacific Sleep Medicine Services, La Jolla,  California,  92037-1205,  United States

      Stanford Sleep Disorders Clinic, Stanford,  California,  94305,  United States

Florida
      St. Petersburg Sleep Disorders Center, St. Petersburg,  Florida,  33707,  United States

Georgia
      Sleep Disorders Center of Georgia, Atlanta,  Georgia,  30342,  United States

Illinois
      Sleep Disorders Center--Division of Neurology, Evanston,  Illinois,  60201,  United States

      Peoria Pulmonary Associates, Ltd., Peoria,  Illinois,  61603,  United States

Indiana
      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

Kentucky
      Chest Medicine Associates DBA/Sleep Medicine Specialists, Louisville,  Kentucky,  40217,  United States

Louisiana
      LSU Health Science Center, Shreveport,  Louisiana,  71130,  United States

Maryland
      Center for Sleep and Wake Disorders, Chevy Chase,  Maryland,  20815,  United States

Massachusetts
      Center for Sleep Diagnostics, Newton,  Massachusetts,  02459,  United States

      Department of Neurology, Worcester,  Massachusetts,  01608,  United States

Missouri
      Washington University -- Sleep Medicine Center, Saint Louis,  Missouri,  63108,  United States

New York
      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

North Carolina
      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

Ohio
      Southwest Cleveland Sleep Center, Middleburg Heights,  Ohio,  44130,  United States

      CSC Research -- Grove City Sleep Diagnostic Center, Grove City,  Ohio,  43123,  United States

Oklahoma
      Lynn Health Science Institute, Oklahoma City,  Oklahoma,  73112,  United States

      Clinical Pharmaceutical Trials, Inc., Tulsa,  Oklahoma,  74104,  United States

Rhode Island
      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

South Carolina
      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

Tennessee
      Sleep Medicine Assoc PLLC -- Summit Medical Center, Hermitage,  Tennessee,  37076,  United States

Texas
      The Houston Sleep Center, Houston,  Texas,  77024,  United States

      Sleep Medicine Associates of Texas, Plano,  Texas,  75093,  United States

Virginia
      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

Washington
      Swedish Sleep Medicine Institute, Seattle,  Washington,  98122,  United States

Canada, Alberta
      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

Canada, Ontario
      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

Canada, Quebec
      Sleep Disorder Centre -- Hopital du Sacre-Coeur, Montreal,  Quebec,  H4J1C5,  Canada

Switzerland
      Neurologische Poliklinik - Universitats Spital Zurich, Zurich,  CH-8091,  Switzerland

Study chairs or principal investigators

William Houghton, MD,  Study Chair,  Orphan Medical   
Harry N Cook, MBA, RPh,  Study Director,  Orphan Medical   

More Information

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.

Study ID Numbers:  OMC-SXB-15
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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