The primary objective of the study is to determine whether armodafinil treatment is more
effective than placebo treatment in patients with excessive sleepiness associated with shift
work disorder (SWD) by measuring improved clinical condition late in the shift, including
the commute home.
Change From Baseline to Endpoint in Global Assessment of Function (GAF) ScoreChange From Baseline to Week 3 in Global Assessment of Functioning
Change From Baseline to Week 6 in Global Assessment of Functioning
Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score
Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score
Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score
Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3
Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities
Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity
Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint
Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome
Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
REM Medical Sleep Center, Phoenix, Arizona 85037, United States
REM Medical Clinical Research, Tucson, Arizona 85712, United States
Central Arkansas Research, Hot Springs, Arkansas 71913, United States
Clinical Study Centers LLC, Little Rock, Arkansas 72205, United States
Peninsula Sleep Center, Burlingame, California 94010, United States
Avastra Clinical Trials, Fountain Valley, California 92708, United States
Pacific Sleep Medicine Services Inc, Los Angeles, California 90048, United States
Southwestern Research Inc, Pasadena, California 91106, United States
Pacific Sleep Medicnie Services Inc, Redlands, California 92373, United States
Stanford University Medical Center, Redwood City, California 94063, United States
Dormir Clinical Trials, Inc., San Diego, California 92121, United States
Southwestern Research Inc, Santa Ana, California 92705, United States
St Johns Medical Plaza Sleep Disorders Center, Santa Monica, California 90404, United States
PAB Clinical Research, Brandon, Florida 33511, United States
MD Clinical, Hallandale Beach, Florida 33009, United States
Compass Research LLC, Orlando, Florida 32806, United States
Broward Research Group, Pembroke Pines, Florida 33026, United States
Miami Research Associates, South Miami, Florida 33143, United States
Florida Sleep Institute, Spring Hill, Florida 34609, United States
Clinical Research Group of St Petersburg, St Petersburg, Florida 33707, United States
SomnoMedics, Tampa, Florida 33607, United States
Neurotrials Research Inc, Atlanta, Georgia 30342, United States
Sleep Disorders Center of Georgia-Peachtree, Atlanta, Georgia 30342, United States
Sleep Disorders Center of Georgia-Gainesville, Gainesville, Georgia 30501, United States
Sleepmed Inc, Macon, Georgia 31201, United States
Chicago Research Center, Chicago, Illinois 60634, United States
Suburban Lung Associates, Elk Grove Village, Illinois 60007, United States
The Center for Sleep and Wake Disorders d/b/a Midwest Neuro, Danville, Indiana 46122, United States
Fort Wayne Neurological Center, Fort Wayne, Indiana 46804, United States
Goldpoint Clinical Research, Indianapolis, Indiana 46260, United States
Rehabilitation Associates of Indiana, Indianapolis, Indiana 46250, United States
University of Iowa Hospitals, Iowa City, Iowa 52242, United States
Vince and Associates Clinical Research, Overland Park, Kansas 66212, United States
Community Research, Crestview, Kentucky 41017, United States
Kentucky Research Group, Louisville, Kentucky 40217, United States
Helene A. Emsellem, MD, Chevy Chase, Maryland 20815, United States
Sleep Health Center, Brighton, Massachusetts 02135, United States
St Mary's of Michigan, Saginaw, Michigan 48604, United States
The Center for Sleep Medicine, Hattiesburg, Mississippi 39402, United States
Clayton Sleep Institute LLC, St Louis, Missouri 63143, United States
Washington University Sleep Medicine Center, St Louis, Missouri 63108, United States
Somnos Laboratories, Inc d/b/a Somnos Clinical Research, Lincoln, Nebraska 68510, United States
Clinical Research Center of Nevada, Las Vegas, Nevada 89104, United States
CliniLabs Inc, New York, New York 10019, United States
Duke Insomnia & Sleep Research Program, Durham, North Carolina 27710, United States
Wake Research Associates, Raleigh, North Carolina 27612, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States
North Coast Clinical Trials Inc, Beachwood, Ohio 44122, United States
Community Research Inc, Cincinnati, Ohio 45227, United States
Tri State Sleep Disorders Center, Cincinnati, Ohio 45246, United States
North Star Medical Research LLC, Middleburg Heights, Ohio 44130, United States
Mercy St Anne Sleep Disorder Center, Toledo, Ohio 43623, United States
Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States
Southeastern PA Medical Institute, Broomall, Pennsylvania 19008, United States
Consolidated Clinical Trials, Jefferson Hills, Pennsylvania 15025, United States
CRI Worldwide, Philadelphia, Pennsylvania 19139, United States
Sleep Lab of Northeastern PA, Summit Hill, Pennsylvania 18411, United States
SleepMed of South Carolina, Columbia, South Carolina 29201, United States
Mid-South Neurology Center, Germantown, Tennessee 38139, United States
FutureSearch Trials of Neurology, Austin, Texas 78756, United States
Kingwood Research Institute, Kingwood, Texas 77339, United States
Sleep Therapy and Research Center, San Antonio, Texas 78250, United States
Avastra Clinical Trials, Midvale, Utah 84047, United States