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) equal to or greater than 10th 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, physical
examination or vital sign 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will be withdrawn from the study)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 major depressive disorder, bipolar disorder, other
significant mood disorders, schizophrenia and other psychotic disorders, eating
disorders, 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 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

- Other criteria apply, please contact the investigator for additional information