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



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:6 - 17
Updated:4/21/2016
Start Date:July 2012
End Date:December 2015

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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

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.


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will be withdrawn from the study)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
We found this trial at
24
sites
Raleigh, North Carolina
2218
mi
from 91732
Raleigh, NC
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1919
mi
from 91732
Atlanta, GA
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1919
mi
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Atlanta, GA
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Birmingham, Alabama
1784
mi
from 91732
Birmingham, AL
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Birmingham, Alabama
1784
mi
from 91732
Birmingham, AL
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Clearwater, Florida
2116
mi
from 91732
Clearwater, FL
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Everett, Washington
984
mi
from 91732
Everett, WA
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Grand Blanc, Michigan
?
mi
from 91732
Grand Blanc, MI
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5593
mi
from 91732
Helsinki,
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Houston, Texas 77054
1358
mi
from 91732
Houston, TX
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Little Rock, Arkansas 72205
1460
mi
from 91732
Little Rock, AR
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Louisville, Kentucky 40291
1822
mi
from 91732
Louisville, KY
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Miami Lakes, Florida
2311
mi
from 91732
Miami Lakes, FL
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Oklahoma City, Oklahoma
1164
mi
from 91732
Oklahoma City, OK
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Orange, California
21
mi
from 91732
Orange, CA
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San Antonio, Texas
1188
mi
from 91732
San Antonio, TX
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San Diego, California
105
mi
from 91732
San Diego, CA
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Seattle, Washington 98105
964
mi
from 91732
Seattle, WA
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Spring Hill, Florida
2114
mi
from 91732
Spring Hill, FL
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Stanford, California
328
mi
from 91732
Stanford, CA
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1937
mi
from 91732
Toledo, OH
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West Chester, Pennsylvania
?
mi
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West Chester, PA
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West Seneca, New York
2187
mi
from 91732
West Seneca, NY
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Winter Park, Florida
2185
mi
from 91732
Winter Park, FL
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