Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
Condition: Excessive Daytime Sleepiness; Narcolepsy; Obstructive Sleep Apnea/Hypopnea Syndrome; Chronic Shift Work Sleep Disorder
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Parasomnias; Narcolepsy; Disorders of Excessive Somnolence; Sleep Disorders, Circadian Rhythm; Sleepiness
Intervention: Armodafinil 100 to 250 mg/day
Intervention description: Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 743.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of
      Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated
      with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep
      Disorder
    

Eligibility criteria:

        Inclusion Criteria:

        Patients are included in the study if all of the following criteria are met:

          -  Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age
             (inclusive) at the beginning of the respective double-blind study, are eligible.

          -  The patient has completed a cephalon-sponsored double-blind study (study
             C10953/3020/NA/MN, C10953/3021/AP/MN, C10953/3022/CM/MN, or C10953/3025/AP/MN), and
             the investigator has recommended they be enrolled.

          -  Patients with OSAHS must continue to be regular users of nCPAP therapy, which the
             investigator considers to remain effective. Patients with chronic SWSD must work 5
             nights/month, with night shifts including at least 6 hours between 2200 and 0800 that
             are no longer than 12 hours in duration.

          -  The patient is considered to be in good health.

          -  Women must be surgically sterile, 2 years postmenopausal, or if of childbearing
             potential, must use 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]).

          -  The patient must be 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:

          -  Have any clinically significant, uncontrolled medical conditions (treated or
             untreated).

          -  Have a probable diagnosis of a current sleep disorder other than the primary diagnosis
             of narcolepsy, OSAHS, or chronic SWSD.

          -  Consume caffeine including coffee, tea and/or other caffeine-containing beverages or
             food averaging more than 600 mg of caffeine.

          -  Use any prescription drugs disallowed by the protocol or clinically significant use of
             over-the-counter (OTC) drugs within 7 days before visit 1.

          -  Have a history of alcohol, narcotic, or any other drug abuse as defined by the
             Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition
             (DSM-IV) (American Psychiatric Association 1994).

          -  Have a positive urine drug screen (UDS) (subjects enrolling in this open-label study
             within 7 days after completing the double-blind study may be enrolled without UDS
             results).

          -  Have a clinically significant deviation from normal in the physical examination.

          -  Are pregnant or lactating. Any woman becoming pregnant during the study will be
             withdrawn from the study.

          -  Have any disorder that may interfere with drug absorption, distribution, metabolism,
             or excretion (including gastrointestinal surgery).

          -  Have a known clinically significant drug sensitivity to stimulants.