Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
NCT ID: NCT01624480
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2012-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Armodafinil
The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.
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.
Armodafinil
The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.
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.
Armodafinil
The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.
Interventions
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Armodafinil
The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
17 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 12
Birmingham, Alabama, United States
Teva Investigational Site 17
Birmingham, Alabama, United States
Teva Investigational Site 7
Little Rock, Arkansas, United States
Teva Investigational Site 18
Orange, California, United States
Teva Investigational Site 16
San Diego, California, United States
Teva Investigational Site 4
Stanford, California, United States
Teva Investigational Site 9
Clearwater, Florida, United States
Teva Investigational Site 26
Miami Lakes, Florida, United States
Teva Investigational Site 5
Spring Hill, Florida, United States
Teva Investigational Site 25
Winter Park, Florida, United States
Teva Investigational Site 1
Atlanta, Georgia, United States
Teva Investigational Site 2
Atlanta, Georgia, United States
Teva Investigational Site 20
Louisville, Kentucky, United States
Teva Investigational Site 15
Grand Blanc, Michigan, United States
Teva Investigational Site 3
West Seneca, New York, United States
Teva Investigational Site 23
Raleigh, North Carolina, United States
Teva Investigational Site 10
Toledo, Ohio, United States
Teva Investigational Site 13
Oklahoma City, Oklahoma, United States
Teva Investigational Site 19
West Chester, Pennsylvania, United States
Teva Investigational Site 8
Houston, Texas, United States
Teva Investigational Site 14
San Antonio, Texas, United States
Teva Investigational Site 27
Everett, Washington, United States
Teva Investigational Site 24
Seattle, Washington, United States
Teva Investigational Site 200
Helsinki, , Finland
Countries
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Other Identifiers
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2012-005510-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C10953/1100
Identifier Type: -
Identifier Source: org_study_id