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The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid \[divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96).
Age
2 - 18 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 9, 2016
Primary Completion Date
October 10, 2019
Completion Date
October 17, 2019
Last Updated
June 4, 2020
106
ACTUAL participants
Anti-epileptics
OTHER
Lead Sponsor
Christoph P Hornik, MD MPH
Collaborators
NCT06700356
NCT07310901
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02531880