Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
NCT ID: NCT00228566
Last Updated: 2013-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
247 participants
INTERVENTIONAL
2005-10-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Armodafinil
Eligibility Criteria
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Inclusion Criteria
* The patient is a man or a woman aged 18 through 65 years of age (inclusive) and English-speaking.
* The patient has excessive sleepiness associated with a diagnosis of narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) according to the International Classification of Sleep Disorders (ICSD) criteria. For OSAHS, the patient must be a regular nasal continuous positive airway pressure (nCPAP) therapy user (usage at least 4 hours/night on at least 70% of nights), must have documented adequate education and intervention efforts to encourage nCPAP therapy use, the patient's nCPAP therapy regimen must be stable for at least 4 weeks prior to study entry, and the patient's nCPAP therapy must be effective in the opinion of the investigator.
* The patient is in good health as determined by a medical and psychiatric history, clinical laboratory tests, vital signs measurements, electrocardiography (ECG), physical examination, and urine drug screen (UDS) at screening.
* If currently receiving therapy for excessive sleepiness associated with their sleep disorder, the patient is dissatisfied because of efficacy and/or safety with their current therapy (i.e., pharmacologic, nap, or bright light therapy), if taken, for excessive sleepiness associated with their sleep disorder.
* The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating at baseline of 4 or more (i.e., at least moderately ill).
* Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD).
* The patient must be willing and able to comply with study procedures and restrictions, including the completion of self-rating scales, and be willing to return to the study center for visits as specified in this protocol.
* The patient may have been prescribed pharmacologic therapy for excessive sleepiness associated with a sleep disorder; however, they must have undergone a washout period of at least 7 days prior to the baseline visit.
Exclusion Criteria
* The patient has any treated or untreated clinically significant uncontrolled medical or psychiatric conditions.
* The patient has a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or other etiology for the complaint of excessive sleepiness.
* The patient consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine/day within 1 week of the start of study drug administration.
* The patient has a medically unexplainable positive UDS at the screening visit.
* The patient has a clinically significant deviation from normal in clinical laboratory test results, vital signs values, or physical examination findings observed at the screening visit.
* The patient has used an investigational drug within 30 days or 5 half-lives (whichever is longer) before study drug administration.
* The patient has used any prescription drugs disallowed by the protocol within 7 days before the baseline visit.
* The patient has a known or suspected hypersensitivity to armodafinil or any compound present in the study drug or related compounds.
* The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from the study).
* The patient has any disorder (including gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
* The patient has a history of alcohol, narcotic,or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV) within the past 5 years.
* The patient has a history of repeated therapeutic failure to therapies for excessive sleepiness.
* The patient previously participated in a clinical study with armodafinil.
18 Years
65 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Principal Investigators
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Sponsor's Medical Expert, MD
Role: STUDY_DIRECTOR
Cephalon
Locations
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West Coast Clinical Trials, Inc
Long Beach, California, United States
Neuro-Therapeutics, Inc
Pasadena, California, United States
Penninsula Research Associates
Rolling Hills Estates, California, United States
Pacific Sleep Program
San Francisco, California, United States
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Neurology Consultants of Tuscaloosa, P.C.
Tuscaloosa, Alabama, United States
Pulmonary Associates
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
PsyPharm Clinical Research
Phoenix, Arizona, United States
PsyPharm Clinical Research Inc.
Tucson, Arizona, United States
Neurology and Clinical Study Center
Little Rock, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
The Sleep Disorders Center of Santa Barbara
Santa Barbara, California, United States
Colorado Sleep Disorder Center
Englewood, Colorado, United States
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, United States
Child Neurology Associates, PC
Atlanta, Georgia, United States
Neurotrials, Inc.
Atlanta, Georgia, United States
Sleepmed Inc.
Macon, Georgia, United States
Savannah Neuurology
Savannah, Georgia, United States
Evanston Northwestern Healthcare, Evanston Hospital
Evanston, Illinois, United States
Convenant Clinic
Waterloo, Iowa, United States
Chest Medicine Assocaites d/b/a/ Sleep Medicine Specialists
Louisville, Kentucky, United States
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
Neurocare. Inc
Newton, Massachusetts, United States
Cumberland Research Associates
Fayetteville, North Carolina, United States
Neurology and Neuro Science Associates
Akron, Ohio, United States
North Coast Clinical Trials, Inc.
Beechwood, Ohio, United States
Jonathan Schwartz
Oklahoma City, Oklahoma, United States
Pacific Sleep Program
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Crozer Chester Medical Center
Upland, Pennsylvania, United States
University Services
West Chester, Pennsylvania, United States
SleepMed of South Carolina
Columbia, South Carolina, United States
Healthstar Physicians
Morristown, Tennessee, United States
Sleep Medicine of Tennesse
Nashville, Tennessee, United States
Metroplex Pulmonary and Sleep Center, PA
Allen, Texas, United States
FutureSearch Trials
Austin, Texas, United States
Sleep Medicine Associates of Texas, P.A
Plano, Texas, United States
Texas Association of Pediatric Neurology
San Antonio, Texas, United States
Vermont Medical Sleep Disorders Center
Essex Junction, Vermont, United States
Sleep Disorders Center of the Mid Atlantic
Vienna, Virginia, United States
Pacific Institute of Medical Science
Kirkland, Washington, United States
Pacific Institute of Mental Health
Seattle, Washington, United States
Countries
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Other Identifiers
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C10953/3046/ES/US
Identifier Type: -
Identifier Source: org_study_id
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