Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients

June 23, 2005 updated by: Orphan Medical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2X2A8
        • Canadian Sleep Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T2B5
        • Vancouver Hospital -- Sleep Disorders Clinic
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L4L2
        • Saint John Regional Hospital -- Somnology Program
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital Sleep Centre -- Ottawa Hospital -- Civic Campus -- Sleep Laboratory
      • Toronto, Ontario, Canada, M5T 3A9
        • The Sleep Disorders Clinic of the Centre for Sleep and Chronobiology
      • Toronto, Ontario, Canada, M8X2W2
        • Brain & Sleep Diagnostic Center
    • Quebec
      • Montreal, Quebec, Canada, H4J1C5
        • Sleep Disorder Centre -- Hopital du Sacre-Coeur
  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Neurologische Poliklinik - Universitats Spital Zurich
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Sleep Disorders Center of Alabama, Inc.
    • California
      • La Jolla, California, United States, 92037-1205
        • Pacific Sleep Medicine Services
      • Stanford, California, United States, 94305
        • Stanford Sleep Disorders Clinic
    • Florida
      • St. Petersburg, Florida, United States, 33707
        • St. Petersburg Sleep Disorders Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Sleep Disorders Center of Georgia
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Sleep Disorders Center--Division of Neurology
      • Peoria, Illinois, United States, 61603
        • Peoria Pulmonary Associates, Ltd.
    • Indiana
      • Danville, Indiana, United States, 46122
        • The Center for Sleep and Wake Disorders/Midwest Neurology
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Neurological Center
      • Fort Wayne, Indiana, United States, 46805
        • Fort Wayne Neurological Center
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Chest Medicine Associates DBA/Sleep Medicine Specialists
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • LSU Health Science Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Center For Sleep and Wake Disorders
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Center for Sleep Diagnostics
      • Worcester, Massachusetts, United States, 01608
        • Department of Neurology
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University -- Sleep Medicine Center
    • New York
      • New York, New York, United States, 10016
        • Sleep/Wake Center 7N2 -- Bellevue Hospital Center
      • Syracuse, New York, United States, 13215
        • The Sleep Center - Community General Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
      • Salisbury, North Carolina, United States, 28144
        • Central Carolina Neurology & Sleep
    • Ohio
      • Grove City, Ohio, United States, 43123
        • CSC Research -- Grove City Sleep Diagnostic Center
      • Middleburg Heights, Ohio, United States, 44130
        • SouthWest Cleveland Sleep Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Tulsa, Oklahoma, United States, 74104
        • Clinical Pharmaceutical Trials, Inc.
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital - Division of Pulmonary, Sleep and Critical Care Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Pulmonary Associates PA
      • Charleston, South Carolina, United States, 29406-7108
        • Low Country Lung and Critical Care PA
      • Columbia, South Carolina, United States, 29201
        • Palmetto Baptist Medical Center Sleep Disorders Center
      • Mount Pleasant, South Carolina, United States, 29464
        • Charleston Pulmonary Associates PA
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
        • Sleep Medicine Assoc PLLC -- Summit Medical Center
    • Texas
      • Houston, Texas, United States, 77024
        • The Houston Sleep Center
      • Plano, Texas, United States, 75093
        • Sleep Medicine Associates of Texas
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sleep Disorders Center -- Eastern Virginia Medical School -- Sentara General Hospital
      • Richmond, Virginia, United States, 23235
        • VCU Health System MCV Hospitals - Sleep Disorders Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Sleep Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orphan Medical

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

November 13, 2002

First Submitted That Met QC Criteria

November 14, 2002

First Posted (Estimate)

November 15, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMC-SXB-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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