Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD

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.