Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Condition: Narcolepsy; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Shift-Work Sleep Disorder
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Parasomnias; Narcolepsy; Sleep Disorders, Circadian Rhythm; Syndrome
Intervention: CEP-10953 (Armodafinil)
Intervention description: Armodafinil (po) 100 to 250 mg/day up to 12 months
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Excessive Sleepiness; Narcolepsy; Cataplexy; Sleep Attacks; Obstructive Sleep Apnea; Obstructive Sleep Hypopnea; nCPAP; Chronic Shift Work Sleep Disorder; Chronic SWSD; Circadian Rhythm Disorder; Shift Worker; Cepahlon; Cephalon, Inc; Nuvigil

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of Armodafinil
      (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12
      months to patients with excessive sleepiness associated with a current diagnosis of
      narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal
      continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder
      (SWSD).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients are included in the study if all of the following criteria are met:

          1. Written informed consent is obtained.

          2. Men and women (outpatients) of any ethnic origin, between 18 and 65 years of age
             (inclusive) are eligible.

          3. The patient has a complaint of excessive sleepiness associated with a current
             diagnosis of:

               -  Narcolepsy-Diagnosis made on the basis of International Classification of Sleep
                  Disorders (ICSD) (American Sleep Disorders Association 2000) criteria.

               -  OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with
                  OSAHS must meet the following nCPAP therapy requirements:

                    -  Previous adequate education and intervention efforts to encourage nCPAP
                       therapy use must be documented.

                    -  A patient's nCPAP therapy regimen must be stable for at least 4 weeks.

                    -  nCPAP therapy is effective, in the opinion of the investigator.

                    -  Evidence of regular nCPAP usage must be shown during a 2 week evaluation
                       period (ie, nCPAP therapy usage of at least 4 hours/night on at least 70% of
                       the nights).

               -  Chronic SWSD-Diagnosis made on the basis of at least minimum ICSD criteria.
                  Furthermore, patients with chronic SWSD must have had excessive sleepiness during
                  night shifts for at least 3 months, work a minimum of 3 night shifts per month
                  that include at least 6 hours between 2200 and 0800 and are no longer than 12
                  hours in duration, and plan to continue to work night shifts throughout the
                  study.

          4. The patient has a Clinical Global Impression of Severity of Disease (CGI-S) rating of
             4 or more. (For patients with OSAHS, the CGI-S scale will be administered after nCPAP
             effectiveness and regular usage is established. For patients with narcolepsy or OSAHS,
             CGI-S will be evaluated to assess general clinical condition. For patients with SWSD,
             CGI-S will be evaluated to assess sleepiness during the night shift including the
             commute to and from work.)

          5. The patient is in good health as determined by a medical and psychiatric history,
             medical examination, electrocardiogram (ECG), serum chemistry and hematology. 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]).

          6. The patient may have been prescribed PROVIGIL or stimulant therapy to treat the sleep
             disorder; however, they must have undergone a washout period of at least 7 days prior
             to screening assessments.

          7. 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:

          1. have any clinically significant, uncontrolled medical conditions (treated or
             untreated)

          2. have a probable diagnosis of a current sleep disorder other than the primary diagnosis
             of narcolepsy, OSAHS, or chronic SWSD

          3. consume caffeine including coffee, tea and/or other caffeine containing beverages or
             food averaging more than 600 mg of caffeine or more than 8 cups of coffee per day

          4. used any prescription drugs disallowed by the protocol or clinically significant use
             of over-the-counter (OTC) drugs within 7 days before the baseline visit

          5. 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)

          6. have a positive UDS at the screening visit

          7. have a clinically significant deviation from normal in the physical examination

          8. are pregnant or lactating. Any woman becoming pregnant during the study will be
             withdrawn from the study

          9. have used an investigational drug within 1 month before the screening visit

         10. have any disorder that may interfere with drug absorption, distribution, metabolism,
             or excretion (including gastrointestinal surgery)

         11. have a known clinically significant drug sensitivity to stimulants