385
Participants
Start Date
March 31, 2010
Primary Completion Date
October 31, 2010
Study Completion Date
October 31, 2010
Armodafinil
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Matching Placebo
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
CliniLabs Inc, New York
Consolidated Clinical Trials, Jefferson Hills
Sleep Lab of Northeastern PA, Summit Hill
Southeastern PA Medical Institute, Broomall
CRI Worldwide, Philadelphia
Helene A. Emsellem, MD, Chevy Chase
Wake Forest University Health Sciences, Winston-Salem
Wake Research Associates, Raleigh
Duke Insomnia & Sleep Research Program, Durham
SleepMed of South Carolina, Columbia
Neurotrials Research Inc, Atlanta
Sleep Disorders Center of Georgia-Peachtree, Atlanta
Sleep Disorders Center of Georgia-Gainesville, Gainesville
Sleepmed Inc, Macon
Compass Research LLC, Orlando
MD Clinical, Hallandale
Broward Research Group, Pembroke Pines
Miami Research Associates, South Miami
PAB Clinical Research, Brandon
SomnoMedics, Tampa
Clinical Research Group of St Petersburg, St. Petersburg
Florida Sleep Institute, Spring Hill
Mid-South Neurology Center, Germantown
The Center for Sleep Medicine, Hattiesburg
Kentucky Research Group, Louisville
Community Research, Crestview
Mercy St Anne Sleep Disorder Center, Toledo
North Coast Clinical Trials Inc, Beachwood
North Star Medical Research LLC, Middleburg Heights
Community Research Inc, Cincinnati
Tri State Sleep Disorders Center, Cincinnati
The Center for Sleep and Wake Disorders d/b/a Midwest Neuro, Danville
Rehabilitation Associates of Indiana, Indianapolis
Goldpoint Clinical Research, Indianapolis
Fort Wayne Neurological Center, Fort Wayne
St Mary's of Michigan, Saginaw
University of Iowa Hospitals, Iowa City
Suburban Lung Associates, Elk Grove Village
Chicago Research Center, Chicago
Washington University Sleep Medicine Center, St Louis
Clayton Sleep Institute LLC, St Louis
Vince and Associates Clinical Research, Overland Park
Somnos Laboratories, Inc d/b/a Somnos Clinical Research, Lincoln
Central Arkansas Research, Hot Springs
Clinical Study Centers LLC, Little Rock
Lynn Health Science Institute, Oklahoma City
Kingwood Research Institute, Kingwood
Sleep Therapy and Research Center, San Antonio
FutureSearch Trials of Neurology, Austin
Avastra Clinical Trials, Midvale
REM Medical Sleep Center, Phoenix
REM Medical Clinical Research, Tucson
Clinical Research Center of Nevada, Las Vegas
Pacific Sleep Medicine Services Inc, Los Angeles
St Johns Medical Plaza Sleep Disorders Center, Santa Monica
Southwestern Research Inc, Pasadena
Dormir Clinical Trials, Inc., San Diego
Pacific Sleep Medicnie Services Inc, Redlands
Southwestern Research Inc, Santa Ana
Avastra Clinical Trials, Fountain Valley
Peninsula Sleep Center, Burlingame
Stanford University Medical Center, Redwood City
Sleep Health Center, Brighton
Lead Sponsor
Cephalon
INDUSTRY