Trial Search Results

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 not accepting patients for this trial.

Lead Sponsor:

Teva Pharmaceutical Industries

Stanford Investigator(s):

Intervention(s):

  • Drug: Armodafinil

Phase:

Phase 1

Eligibility


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   will be withdrawn from the study)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

Ages Eligible for Study

6 Years - 17 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paul Stowers
650-721-7551
Recruiting