A Randomized, Open-Label Study to Characterize 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

Teva Branded Pharmaceutical Products R&D, Inc.24 sites in 2 countries40 target enrollmentJuly 2012

ConditionsNarcolepsy

InterventionsArmodafinil

DrugsArmodafinil

Overview

Phase: Phase 1
Intervention: Armodafinil
Conditions: Narcolepsy
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Enrollment: 40
Locations: 24
Primary Endpoint: Predicted accumulation ratio
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

December 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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 (Any patient becoming pregnant during the study will be withdrawn from the study)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.

Arms & Interventions

Armodafinil 50 mg

In period 1, patients will receive a single 50-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose daily on days 1 through 42.

Intervention: Armodafinil

Armodafinil 100 mg

In period 1, patients will receive a single 100 mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1 then daily 100-mg doses on days 2 through 42.

Intervention: Armodafinil

Armodafinil 150 mg

In period 1, patients will receive a single 150-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1, 100-mg doses on days 2 and 3, then daily 150-mg doses on days 4 through 42.

Intervention: Armodafinil