Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

Inclusion Criteria:

• Written informed consent is obtained from each patient's parent or legal guardian and written assent is obtained from each patient.
• The patient is a male or female 6 through 17 years of age with a body mass index (BMI) within the 5th to 97th percentile for age and gender, inclusive.
• The patient has a diagnosis of narcolepsy with cataplexy or narcolepsy without cataplexy according to the criteria established by the International Classification of Sleep Disorders (ICSD)-2 for narcolepsy.

Exclusion Criteria:

• The patient has any clinically significant uncontrolled medical condition (treated or untreated) other than narcolepsy.
• The patient has a clinically significant deviation from normal in ECG or physical examination findings, as determined by the investigator or medical monitor.
• The patient is pregnant or lactating. (Any patient becoming pregnant during the study will be withdrawn from the study)
• The patient has any history of seizures, including febrile seizures, or a family history of seizures (in parents or siblings) which is not a consequence of trauma, stroke, or metabolic disturbance.
• The patient has a history of head trauma associated with loss of consciousness.
• The patient has current suicidal ideation, a history of a suicidal ideation, or a history of a suicide attempt.
• The patient has a history of any Axis I psychiatric disorder including, but not limited to, major depressive disorder, bipolar disorder, other mood disorders, schizophrenia and other psychotic disorders, anxiety disorders, eating disorders, or sleep disorders other than narcolepsy, or has a family history of suicide.
• The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.

• The patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug.

  • The patient has used any monoamine oxidase inhibitors (MAOIs) or stimulants within 14 days or 5 half-lives (whichever is longer) of the baseline visit.
  • The patient has used modafinil or armodafinil within 4 weeks of the baseline visit.
  • The patient has used an inducer of CYP3A4/5 within 28 days prior to study drug administration.
  • The patient has used an inhibitor of CYP3A4/5 within 14 days or 5 half lives (whichever is longer) prior to study drug administration.
  • The patient has used any herbal or nutritional supplements within 2 weeks before the 1st dose of study drug.
  • The patient has used any systemic or topical prescription, or nonprescription (over-the-counter [OTC]) medication (except acetaminophen or ibuprofen) within 2 weeks or 5 half lives (whichever is longer) before the 1st dose of study drug. (NOTE: Medications for the treatment of cataplexy will be permitted based on the review of the medical monitor if the patient has been on a stable dose for at least 1 month). In addition, the use of some topical medications may be permitted with approval from the medical monitor. No medication will be permitted within 2 hours before or after study drug administration.
  • The patient has a known sensitivity or idiosyncratic reaction to any compound present in modafinil or armodafinil, their related compounds, or to any metabolites or compound listed as being present in these medications.
  • The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions

  • The patient has 1 or more clinical laboratory test values outside the range specified below, or any other clinically significant laboratory abnormality as determined by the investigator or medical monitor:

    • hemoglobin value of less than 11.0 g/dL
    • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value more than twice the upper limit of the normal range (ULN) total bilirubin value of more than the ULN