Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
- Conditions
- Excessive Daytime SleepinessNarcolepsyObstructive Sleep Apnea/Hypopnea SyndromeChronic Shift Work Sleep Disorder
- Interventions
- Registration Number
- NCT00228553
- Lead Sponsor
- Cephalon
- Brief Summary
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 743
Patients are included in the study if all of the following criteria are met:
- Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age (inclusive) at the beginning of the respective double-blind study, are eligible.
- The patient has completed a cephalon-sponsored double-blind study (study C10953/3020/NA/MN, C10953/3021/AP/MN, C10953/3022/CM/MN, or C10953/3025/AP/MN), and the investigator has recommended they be enrolled.
- Patients with OSAHS must continue to be regular users of nCPAP therapy, which the investigator considers to remain effective. Patients with chronic SWSD must work 5 nights/month, with night shifts including at least 6 hours between 2200 and 0800 that are no longer than 12 hours in duration.
- The patient is considered to be in good health.
- Women must be surgically sterile, 2 years postmenopausal, or if of childbearing potential, must use a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]).
- The patient must be willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- Have any clinically significant, uncontrolled medical conditions (treated or untreated).
- Have a probable diagnosis of a current sleep disorder other than the primary diagnosis of narcolepsy, OSAHS, or chronic SWSD.
- Consume caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine.
- Use any prescription drugs disallowed by the protocol or clinically significant use of over-the-counter (OTC) drugs within 7 days before visit 1.
- Have a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IV) (American Psychiatric Association 1994).
- Have a positive urine drug screen (UDS) (subjects enrolling in this open-label study within 7 days after completing the double-blind study may be enrolled without UDS results).
- Have a clinically significant deviation from normal in the physical examination.
- Are pregnant or lactating. Any woman becoming pregnant during the study will be withdrawn from the study.
- Have any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- Have a known clinically significant drug sensitivity to stimulants.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1 Armodafinil 100 to 250 mg/day Armodafinil 100 to 250 mg/day
- Primary Outcome Measures
Name Time Method Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years) End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (98)
Sleep Disorders Center of GA
🇺🇸Atlanta, Georgia, United States
St. Petersburg Sleep Disorder
🇺🇸St. Petersburg, Florida, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Baycrest Hospital
🇨🇦Toronto, Ontario, Canada
Radiant Research San Diego
🇺🇸San Diego, California, United States
Psypharma Clinical Research
🇺🇸Phoenix, Arizona, United States
St. Thomas Sleep Disorders Cen
🇺🇸Nashville, Tennessee, United States
Sleep Disorders Ctr of Alabama
🇺🇸Birmingham, Alabama, United States
Pulmonary Associates, PA
🇺🇸Phoenix, Arizona, United States
Clinical Rsch Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Community Research Management
🇺🇸Cincinnati, Ohio, United States
Pacific Sleep Medicine Service
🇺🇸San Diego, California, United States
BMR HealthQuest
🇺🇸San Diego, California, United States
Tri State Sleep Disorders Cent
🇺🇸Cincinnati, Ohio, United States
Houston Sleep Center
🇺🇸Houston, Texas, United States
VA Medical CenterSleep Diagnos
🇺🇸Houston, Texas, United States
Radiant Research Salt Lake
🇺🇸Salt Lake City, Utah, United States
Hephata Klinik
🇩🇪Schwalmstadt, Germany
Southwest Cleveland Sleep Cent
🇺🇸Middleburg Heights, Ohio, United States
Dept Veterans Affairs Dayton
🇺🇸Dayton, Ohio, United States
Neurocare, Inc.
🇺🇸Newton, Massachusetts, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
Swedish Sleep Medicine Institute
🇺🇸Seattle, Washington, United States
Sentara Norfolk General Hospit
🇺🇸Norfolk, Virginia, United States
Central Carolina Neurology Sle
🇺🇸Salisbury, North Carolina, United States
Regional Pulmonary and Sleep
🇺🇸Elkton, Maryland, United States
Clinilabs / Sleep Disorders In
🇺🇸New York, New York, United States
Sleep-Wake Disorder Center
🇺🇸Winter Park, Florida, United States
Washington University School o
🇺🇸St. Louis, Missouri, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Center for Sleep Disorders
🇺🇸Danville, Indiana, United States
Community Research
🇺🇸Crestview, Kentucky, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Vital re:Search
🇺🇸Greensboro, North Carolina, United States
St. Vincent Mercy Medical Cent
🇺🇸Toledo, Ohio, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Neurotrials Research
🇺🇸Atlanta, Georgia, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
Allegiance Research Specialist
🇺🇸Wauwatosa, Wisconsin, United States
Vince and Associates Clinical
🇺🇸Overland Park, Kansas, United States
Chest Medicine Associates DBA
🇺🇸Louisville, Kentucky, United States
West Parry Sound Health Center
🇨🇦Parry Sound, Ontario, Canada
Hopital Guy de Chauliac
🇫🇷Montpellier, Cedex 05, France
Niagara Clinical Research
🇨🇦Niagara Falls, Ontario, Canada
Clinical Pharmaceutical Trials
🇺🇸Tulsa, Oklahoma, United States
Stanford University
🇺🇸Stanford, California, United States
Peoria Pulmonary Associates
🇺🇸Peoria, Illinois, United States
Central Arkansas Research
🇺🇸Hot Springs, Arkansas, United States
Hospital Henri-Mondor
🇫🇷Creteil, France
New York University
🇺🇸New York, New York, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
City Clinical Hospital 83
🇷🇺Moscow, Russian Federation
Sleep and Neuropsychiatry Cent
🇨🇦Scarborough, Ontario, Canada
University of Freiburg
🇩🇪Freiburg, Germany
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Universitaires de Strasbourg
🇫🇷Strasbourg, Cedex, France
Hopital Antoine Beclere
🇫🇷Clamart, France
Klinikum der Philipps
🇩🇪Marburg, Germany
University of Regensburg
🇩🇪Regensburg, Germany
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Neurology Associates of Hickor
🇺🇸Hickory, North Carolina, United States
Advanced Clinical Research Ins
🇺🇸Anaheim, California, United States
Southwestern Research
🇺🇸Beverly Hills, California, United States
Sleep Clinic of San Francisco
🇺🇸San Francisco, California, United States
St. Johns Medical Plaza Sleep
🇺🇸Santa Monica, California, United States
SLEEPMED, Inc.
🇺🇸Macon, Georgia, United States
Henry Lahmeyer, MD
🇺🇸Northfield, Illinois, United States
Radiant Research Marietta
🇺🇸Marietta, Georgia, United States
Neurotrials Research of New Or
🇺🇸Metairie, Louisiana, United States
Graves Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Topeka Pulmonary
🇺🇸Topeka, Kansas, United States
CNS Research Institute
🇺🇸Clementon, New Jersey, United States
Center for Sleep/Wake Disorder
🇺🇸Chevy Chase, Maryland, United States
All Trials Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
North Coast Clinical Trials
🇺🇸Beechwood, Ohio, United States
Consolidated Clinical Trials
🇺🇸Pittsburgh, Pennsylvania, United States
Ohio Sleep Medicine-Neurosci
🇺🇸Dublin, Ohio, United States
Capital Region Sleep Disorders
🇺🇸Carlisle, Pennsylvania, United States
Lowcountry Lung and Critical
🇺🇸Charleston, South Carolina, United States
Sleep Medicine Institute
🇺🇸Dallas, Texas, United States
Sadler Clinic
🇺🇸The Woodlands, Texas, United States
St. George Hospital
🇦🇺Kogarah, New South Wales, Australia
Canadian Sleep Institute
🇨🇦Calgary, Alberta, Canada
Sleep Clinic
🇨🇦Kitchener, Ontario, Canada
City Clinical Hospital 33
🇷🇺Moscow, Russian Federation
Northshore Research Associates
🇺🇸Slidell, Louisiana, United States
Sleep Disorders Center
🇺🇸Hattiesburg, Mississippi, United States
SleepMed of South Carolina
🇺🇸Columbia, South Carolina, United States
Multifunction Center of Neurol
🇷🇺Samara, Russian Federation
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Monash Medical Center
🇦🇺Clayton, Victoria, Australia
SomniCare Sleep Institute
🇵🇷San Juan, Puerto Rico
Clinical Hospital Russian Scie
🇷🇺Saint Petersburg, Russian Federation
Melbourne Sleep Disorders Ctr.
🇦🇺East Melbourne, Victoria, Australia
University of Iowa Hospitals
🇺🇸Iowa City, Iowa, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States