The primary objective of this study is to determine whether treatment with CEP 10953 is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) and by Clinical Global Impression of Change (CGI C) ratings (for sleepiness during night shifts including the commute to and from work) at week 12 (or last postbaseline visit).

Condition	Treatment or Intervention	Phase
Excessive Sleepiness Shift Work Sleep Disorder	Drug: CEP-10953	Phase III

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Patients are included in the study if all of the following criteria are met:

• Written informed consent is obtained.
• The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
• The patient has a complaint of excessive sleepiness.
• The patient has a diagnosis of SWSD according to International Classification of Sleep Disorders (ICSD) criteria, and must have had excessive sleepiness during night shifts for at least 3 months.
• The patient must work at least 5 night shifts per month, of which at least 3 nights are consecutive, and plan to maintain this schedule.
• The patient must work night shifts that include at least 6 hours between 2200 and 0800 and be no longer than 12 hours in duration.
• The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology.
• Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive, or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. Steroidal contraceptives must be used with a barrier method while taking the study drug and for at least a full cycle after discontinuation of the study drug.
• The patient has a mean sleep latency of 6 minutes or less as determined by the MSLT
• The patient has a CGI-S rating as it pertains to sleepiness during night shifts including the commute to and from work.
• The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness during the night shift.
• The patient is able to complete self rating scales and computer-based testing.
• The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

• has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
• has a probable diagnosis of a current sleep disorder other than SWSD
• consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day
• used any prescription drugs disallowed by the protocol or clinically significant use of over the-counter (OTC) drugs within 7 days before the screening/baseline visit
• 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)
• has a positive urine drug screen (UDS) at the screening visit
• has a clinically significant deviation from normal in the physical examination
• is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
• has used an investigational drug within 1 month before the screening visit
• has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
• has a known clinically significant drug sensitivity to stimulants or modafinil

Alabama
      Sleep Disorders Center of Alabama, Birmingham,  Alabama,  35213,  United States; Recruiting
Arizona
      PsyPharma Clincial Research, Inc., Phoenix,  Arizona,  85050,  United States; Recruiting
      PsyPharma Clinical Research Inc., Tuscon,  Arizona,  85712,  United States; Recruiting
Arkansas
      Central Arkansas Research, Hot Springs,  Arkansas,  71913,  United States; Recruiting
California
      Pacific Sleep Medicine Services, Inc, San Diego,  California,  92121,  United States; Recruiting
      HealthQuest Clinical Trials, San Diego,  California,  92123,  United States; Recruiting
      Pacific Sleep Medicine Services, Inc, Los Angeles,  California,  90048,  United States; Recruiting
      Stanford Sleep Disorder Clinic, Stanford,  California,  94305,  United States; Recruiting
Colorado
      University of Colorado, Boulder,  Colorado,  80309,  United States; Recruiting
Florida
      Sleep Disorders Center of SW Florida, Naples,  Florida,  34110,  United States; Recruiting
Georgia
      Neurotrials Research Inc, Atlanta,  Georgia,  30342,  United States; Recruiting
      Sleep Disorders Center of Georgia, Atlanta,  Georgia,  30342,  United States; Recruiting
Illinois
      Henry W. Lahmeyer, MD and Associates, Northfield,  Illinois,  60093,  United States; Recruiting
      Rush University Medical Center, Chicago,  Illinois,  60612-3833,  United States; Recruiting
Indiana
      The Center for Sleep and Wake Disorders/Midwest Neurology, Danville,  Indiana,  46122,  United States; Recruiting
      Fort Wayne Neurological Center, Fort Wayne,  Indiana,  46804,  United States; Recruiting
Kansas
      Vince and Associates Clinical Research, Overland Park,  Kansas,  66211,  United States; Recruiting
Louisiana
      NeuroTrials Research of New Orleans, Metaire,  Louisiana,  70001,  United States; Recruiting
Maryland
      Center for Sleep and Wake Disorders, Chevy Chase,  Maryland,  20815,  United States; Recruiting
Massachusetts
      McLean Hospital Sleep Research Center, Belmont,  Massachusetts,  02478,  United States; Recruiting
      Brigham & Women's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States; Recruiting
Nevada
      Clinical Research Center of Nevada, Las Vegas,  Nevada,  89104,  United States; Recruiting
New York
      Clinilabs, Inc, New York,  New York,  10025,  United States; Recruiting
North Carolina
      Central Carolina Neurology and Sleep, PA, Salisbury,  North Carolina,  28144,  United States; Recruiting
      ALL-TRIALS Clinical Research, LLC, Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Wake Research Associates, LLC, Raleigh,  North Carolina,  27612,  United States; Recruiting
      Neurology Associates of Hickory, Hickory,  North Carolina,  28602,  United States; Recruiting
Ohio
      Ohio Sleep Medicine and Neuroscience Institute, Inc., Dublin,  Ohio,  43017,  United States; Recruiting
      Community Resrarch Management Associates, Inc., Cincinnati,  Ohio,  45219,  United States; Recruiting
      Saint Vincent Mercy Medical Center - Sleep Disorders Center, Toledo,  Ohio,  43606,  United States; Recruiting
      VA Medical Center, Dayton,  Ohio,  45428,  United States; Recruiting
Pennsylvania
      Center for Sleep Disorders, Inc, Pottstown,  Pennsylvania,  19464,  United States; Recruiting
South Carolina
      SleepMed of South Carolina, Columbia,  South Carolina,  29201,  United States; Recruiting
Texas
      FutureSearch Trials, Austin,  Texas,  78756,  United States; Recruiting
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Utah
      Radiant Research, Salth Lake City, 64th South, Salt Lake City,  Utah,  84107,  United States; Recruiting
Virginia
      Sleep Disorders Center, EVMS, Norfolk,  Virginia,  23507,  United States; Recruiting
Washington
      Swedish Sleep Medicine Institute, Seattle,  Washington,  98122,  United States; Recruiting
Canada, Ontario
      Toronto West Hospital, Toronto,  Ontario,  M5T 2S8,  Canada; Recruiting
      Sleep and Neuropsychiatry Centre, Scarborough,  Ontario,  M1S 1T7,  Canada; Recruiting
      Glengrove Clinic Inc., Toronto,  Ontario,  M8X 2W2,  Canada; Recruiting
      Niagara Clinical Research, Niagara Falls,  Ontario,  L2G 1J4,  Canada; Recruiting

Study ID Numbers:  C10953/3022/CM/MN
Record last reviewed:  July 2004
Record first received:  March 25, 2004
ClinicalTrials.gov Identifier:  NCT00080288
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-18