Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
Condition: Excessive Sleepiness; Shift Work Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias; Disorders of Excessive Somnolence; Sleep Disorders, Circadian Rhythm; Sleepiness
Intervention: Armodafinil 150 mg/day; Placebo
Intervention description: Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked.; Matching placebo tablets once daily
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Excessive Sleepiness; Chronic Shift Work Sleep Disorder; Chronic SWSD; Circadian Rhythm Disorder; Shift Worker; Cephalon; Cephalon, Inc; Nuvigil

Summary:

      The primary objective of this study is to determine whether treatment with Armodafinil
      (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) (average of 4 naps at 0200, 0400, 0600,
      and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.
    

Eligibility 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