Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.
Stanford is currently accepting patients for this trial.
Teva Branded Pharmaceutical Products R&D, Inc.
- Drug: Armodafinil
- 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.
- 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
- 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will be withdrawn from the study)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
- 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
- The patient has used an inducer of CYP3A4/5 within 28 days prior to study drug
- 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
Ages Eligible for Study
6 Years - 17 Years
Genders Eligible for Study