Pharmacokinetics of Anti-epileptic Drugs in Obese Children
NCT ID: NCT02993861
Last Updated: 2020-06-04
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
106 participants
OBSERVATIONAL
2016-12-09
2019-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Levetiracetam
Children with epilepsy who are treated with levetiracetam per local standard of care
Anti-epileptics
Valproic Acid
Children with epilepsy who are treated with valproic acid per local standard of care
Anti-epileptics
Topiramate
Children with epilepsy who are treated with topiramate per local standard of care
Anti-epileptics
Oxcarbazepine
Children with epilepsy who are treated with oxcarbazepine per local standard of care
Anti-epileptics
Interventions
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Anti-epileptics
Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 95th percentile for age and sex, based on CDC recommendations
* Informed consent/HIPAA from the parent/legal guardian and assent (as applicable)
* Receiving ≥ 1 of the study drugs per local standard of care
Exclusion Criteria
2 Years
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The Emmes Company, LLC
INDUSTRY
Christoph P Hornik, MD MPH
OTHER
Responsible Party
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Christoph P Hornik, MD MPH
Associate Professor of Pediatrics
Principal Investigators
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Kanecia Zimmerman, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Duke Medical Center/Duke Clinical Research Institute
Locations
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The Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Louisville Norton Childrens Hospital
Louisville, Kentucky, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Coastal Children's Services
Wilmington, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, United States
Countries
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Other Identifiers
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Pro00070924
Identifier Type: -
Identifier Source: org_study_id
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