Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

Completed · Phase 3 · Has a placebo group

Conditions studied: Narcolepsy

In brief

This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

Key facts

Study ID

NCT00066170

Run by

Jazz Pharmaceuticals

People needed

231

Starts

2003-04-01

Expected to finish

2004-11-01

Last updated by the study team

2011-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be included in the trial if they:
• Have signed and dated an informed consent prior to beginning protocol required procedures.
• Are willing and able to complete the entire trial as described in the protocol.
• Are 18 years of age or older.
• Fulfill the International Classification of Sleep Disorders criteria for the diagnosis of narcolepsy.
• Are taking stable doses of modafinil (200 to 600 mg/day) for the treatment of daytime sleepiness for a period of three months or greater and the modafinil dose has been stable for at least 1 month prior to entering this trial
• Females may be included who are surgically sterile, two years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) 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 the trial to include transportation to and from the 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…

• Patients will be excluded from the trial if they:
• Have received gamma-hydroxybutyrate in the last 30 days.
• Have taken any investigational therapy within the 30-day period prior to the initial screening visit (Visit 1) for this trial.
• Have sleep apnea syndrome, defined as an Apnea Index > 10 per hour or an AHI (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 (e.g., severe periodic leg movement syndrome as determined by the investigator, sleep apnea, sleep deprivation).
• Are 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 event if they are willing to washout anticonvulsants for the trial.
• Are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, 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 the 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 a current or recent (within one year) history of a substance use disorder including alcohol abuse as defined by the DSM-IV.
• Have a 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 the 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 the last six months.
• Have an occupation that requires variable shift work or routine night shift.
• Have a clinically significant history of seizure disorder either past or present, 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

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• St. Jude Medical Center -- Sleep Disorders Institute — Fullerton, California, United States
• Pacific Sleep Medicine Services, Inc. — Los Angeles, California, United States
• Neuro-Therapeutics, Inc. — Pasadena, California, United States
• Pacific Sleep Medicine Services, Inc. — San Diego, California, United States
• Stanford Sleep Disorders Clinic — Stanford, California, United States
• Clinical Research Group of St. Petersburg, Inc. — St. Petersburg, Florida, United States
• Peoria Pulmonary Associates, Ltd — Peoria, Illinois, United States
• The Center for Sleep and Wake Disorders/Midwest Neurology — Danville, Indiana, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• Community Research & Sleep Management Institute — Crestview Hills, Kentucky, United States
• Chest Medicine Associates DBA -- Sleep Medicine Specialists — Louisville, Kentucky, United States
• The Center for Sleep & Wake Disorders — Chevy Chase, Maryland, United States
• Sleep Disorders Center -- Union Hospital of Cecil County — Elkton, Maryland, United States
• Sleep Medicine Associates of Maryland — Towson, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Washington University Sleep Center — St Louis, Missouri, United States
• New Jersey Neuroscience Institute at JFK Medical Center — Edison, New Jersey, United States
• Sleep Disorders Center of Rochester — Rochester, New York, United States
• Strong Sleep Disorders Center — Rochester, New York, United States
• Raleigh Neurology Associates — Raleigh, North Carolina, United States
• ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder — Winston-Salem, North Carolina, United States
• Cincinnati Clinic & Sleep Management Institute — Cincinnati, Ohio, United States
• Community Research Management Associates,Inc. — Cincinnati, Ohio, United States
• CSC Research -- Grove City Sleep Diagnostic Center — Grove City, Ohio, United States

Full record on ClinicalTrials.gov

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