Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Intervention: Armodafinil; Armodafinil; Placebo
Intervention description: Armodafinil 250 mg once daily in the morning; Armodafinil 150 mg once daily in the morning; 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: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Narcolepsy; Excessive Sleepiness; Cataplexy; Sleep Attacks; Excessive Sleepiness associated with Narcolepsy; 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 narcolepsy by measuring mean sleep latency from the Maintenance of
      Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500)
      and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general
      condition) at week 12 (or last postbaseline observation)
    

Eligibility criteria:

        Diagnosis and Criteria for Inclusion:

        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 current diagnosis of narcolepsy according to ICSD criteria.

          -  The patient is in good health as determined by a medical and psychiatric history,
             physical examination, electrocardiogram (ECG), and serum chemistry, hematology, and
             urinalysis.

          -  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 [oral, implanted, and Depo-Provera contraceptives
             must be used in conjunction with a barrier method], or intrauterine device [IUD]) and
             agree to continued use of this method for the duration of the study.

          -  The patient has a mean sleep latency of 6 minutes or less as determined by the
             Multiple Sleep Latency Test (MSLT) (performed at 0900, 1100, 1300, and 1500).

          -  The patient has a CGI-S (Clinical Global Impression of Severity of Illness) rating of
             4 or more.

          -  The patient does not have any medical or psychiatric disorders that could account for
             the excessive daytime sleepiness.

          -  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.

        Criteria for Exclusion:

        Patients are excluded from participating in this study if 1 or more of the following
        criteria are met. The patient:

          -  has any clinically significant, uncontrolled medical or psychiatric conditions
             (treated or untreated)

          -  has a probable diagnosis of a current sleep disorder other than narcolepsy

          -  consumed 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 second screening 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 UDS at the screening visit, without medical explanation

          -  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