Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Condition: Excessive Daytime Sleepiness; Narcolepsy; Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Narcolepsy; Disorders of Excessive Somnolence; Syndrome; Sleepiness
Intervention: Armodafinil
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: 247.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess patient reported outcomes with armodafinil treatment
      in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to
      engage in life activities (ie, daily or work and family and/or social activities), and
      effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also
      be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent is obtained.

          -  The patient is a man or a woman aged 18 through 65 years of age (inclusive) and
             English-speaking.

          -  The patient has excessive sleepiness associated with a diagnosis of narcolepsy or
             Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) according to the International
             Classification of Sleep Disorders (ICSD) criteria. For OSAHS, the patient must be a
             regular nasal continuous positive airway pressure (nCPAP) therapy user (usage at least
             4 hours/night on at least 70% of nights), must have documented adequate education and
             intervention efforts to encourage nCPAP therapy use, the patient's nCPAP therapy
             regimen must be stable for at least 4 weeks prior to study entry, and the patient's
             nCPAP therapy must be effective in the opinion of the investigator.

          -  The patient is in good health as determined by a medical and psychiatric history,
             clinical laboratory tests, vital signs measurements, electrocardiography (ECG),
             physical examination, and urine drug screen (UDS) at screening.

          -  If currently receiving therapy for excessive sleepiness associated with their sleep
             disorder, the patient is dissatisfied because of efficacy and/or safety with their
             current therapy (i.e., pharmacologic, nap, or bright light therapy), if taken, for
             excessive sleepiness associated with their sleep disorder.

          -  The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating at
             baseline of 4 or more (i.e., at least moderately ill).

          -  Women of childbearing potential (not surgically sterile or 2 years postmenopausal)
             must use a medically accepted method of contraception and must agree to continue use
             of this method for the duration of the study and for 30 days after participation in
             the study. Acceptable methods of contraception include abstinence, barrier method with
             spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in
             conjunction with a barrier method, or intrauterine device (IUD).

          -  The patient must be willing and able to comply with study procedures and restrictions,
             including the completion of self-rating scales, and be willing to return to the study
             center for visits as specified in this protocol.

          -  The patient may have been prescribed pharmacologic therapy for excessive sleepiness
             associated with a sleep disorder; however, they must have undergone a washout period
             of at least 7 days prior to the baseline visit.

        Exclusion Criteria:

        Patients are excluded from participating in this study if any of the following criteria are
        met:

          -  The patient has any treated or untreated clinically significant uncontrolled medical
             or psychiatric conditions.

          -  The patient has a probable diagnosis of a current sleep disorder other than the
             primary diagnosis of narcolepsy, OSAHS, or other etiology for the complaint of
             excessive sleepiness.

          -  The patient consumes caffeine including coffee, tea and/or other caffeine-containing
             beverages or food averaging more than 600 mg of caffeine/day within 1 week of the
             start of study drug administration.

          -  The patient has a medically unexplainable positive UDS at the screening visit.

          -  The patient has a clinically significant deviation from normal in clinical laboratory
             test results, vital signs values, or physical examination findings observed at the
             screening visit.

          -  The patient has used an investigational drug within 30 days or 5 half-lives (whichever
             is longer) before study drug administration.

          -  The patient has used any prescription drugs disallowed by the protocol within 7 days
             before the baseline visit.

          -  The patient has a known or suspected hypersensitivity to armodafinil or any compound
             present in the study drug or related compounds.

          -  The patient is pregnant or lactating. (Any patients becoming pregnant during the study
             will be withdrawn from the study).

          -  The patient has any disorder (including gastrointestinal surgery) that may interfere
             with drug absorption, distribution, metabolism, or excretion.

          -  The patient 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) within the past 5 years.

          -  The patient has a history of repeated therapeutic failure to therapies for excessive
             sleepiness.

          -  The patient previously participated in a clinical study with armodafinil.