Pharmacokinetics of Anti-epileptic Drugs in Obese Children
1 other identifier
observational
106
1 country
10
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2016
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2016
CompletedFirst Submitted
Initial submission to the registry
December 13, 2016
CompletedFirst Posted
Study publicly available on registry
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2019
CompletedJune 4, 2020
June 1, 2020
2.8 years
December 13, 2016
June 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Steady-state pharmacokinetics area under the curve
Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics maximum concentration
Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics time to reach maximum concentration
Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics oral apparent volume of distribution
Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics half life
Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics oral apparent clearance
Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics absorption rate constant
Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Secondary Outcomes (1)
Serious adverse events
Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Study Arms (4)
Levetiracetam
Children with epilepsy who are treated with levetiracetam per local standard of care
Valproic Acid
Children with epilepsy who are treated with valproic acid per local standard of care
Topiramate
Children with epilepsy who are treated with topiramate per local standard of care
Oxcarbazepine
Children with epilepsy who are treated with oxcarbazepine per local standard of care
Interventions
Eligibility Criteria
Children with epilepsy who are inpatients in local hospital or managed in outpatient settings - community sample.
You may qualify if:
- years to \< 18 years at the time of enrollment
- 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
You may not qualify if:
- Known pregnancy as determined via interview or test results, if available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
The Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Nemours Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803, United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30324, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Louisville Norton Childrens Hospital
Louisville, Kentucky, 40202, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Duke University Health System
Durham, North Carolina, 27705, United States
Coastal Children's Services
Wilmington, North Carolina, 28401, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390-8589, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kanecia Zimmerman, MD, MPH
Duke Medical Center/Duke Clinical Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
December 13, 2016
First Posted
December 15, 2016
Study Start
December 9, 2016
Primary Completion
October 10, 2019
Study Completion
October 17, 2019
Last Updated
June 4, 2020
Record last verified: 2020-06