DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017