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

Completed · Phase 3

Conditions studied: Narcolepsy

In brief

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.

Key facts

Study ID: NCT00049803
Run by: Orphan Medical
People needed: 200
Starts: 2000-12-01
Expected to finish: 2004-04-01
Last updated by the study team: 2005-06-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Sleep Disorders Center of Alabama, Inc. — Birmingham, Alabama, United States
Pacific Sleep Medicine Services — La Jolla, California, United States
Stanford Sleep Disorders Clinic — Stanford, California, United States
St. Petersburg Sleep Disorders Center — St. Petersburg, Florida, United States
Sleep Disorders Center of Georgia — Atlanta, Georgia, United States
Sleep Disorders Center--Division of Neurology — Evanston, Illinois, United States
Peoria Pulmonary Associates, Ltd. — Peoria, Illinois, United States
The Center for Sleep and Wake Disorders/Midwest Neurology — Danville, Indiana, United States
Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
Chest Medicine Associates DBA/Sleep Medicine Specialists — Louisville, Kentucky, United States
LSU Health Science Center — Shreveport, Louisiana, United States
Center for Sleep and Wake Disorders — Chevy Chase, Maryland, United States
Center for Sleep Diagnostics — Newton, Massachusetts, United States
Department of Neurology — Worcester, Massachusetts, United States
Washington University -- Sleep Medicine Center — St Louis, Missouri, United States
Sleep/Wake Center 7N2 -- Bellevue Hospital Center — New York, New York, United States
The Sleep Center - Community General Hospital — Syracuse, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
Raleigh Neurology Associates — Raleigh, North Carolina, United States
Central Carolina Neurology & Sleep — Salisbury, North Carolina, United States
CSC Research -- Grove City Sleep Diagnostic Center — Grove City, Ohio, United States
Southwest Cleveland Sleep Center — Middleburg Heights, Ohio, United States
Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
Clinical Pharmaceutical Trials, Inc. — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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