Pharmacokinetics of Anti-epileptic Drugs in Obese Children
- Conditions
- ObeseEpilepsy
- Interventions
- Other: Anti-epileptics
- Registration Number
- NCT02993861
- Lead Sponsor
- Christoph P Hornik, MD MPH
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 2 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
- Known pregnancy as determined via interview or test results, if available
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Topiramate Anti-epileptics Children with epilepsy who are treated with topiramate per local standard of care Valproic Acid Anti-epileptics Children with epilepsy who are treated with valproic acid per local standard of care Levetiracetam Anti-epileptics Children with epilepsy who are treated with levetiracetam per local standard of care Oxcarbazepine Anti-epileptics Children with epilepsy who are treated with oxcarbazepine per local standard of care
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Serious adverse events Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Trial Locations
- Locations (10)
Nemours Alfred I. DuPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Childrens Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Louisville Norton Childrens Hospital
🇺🇸Louisville, Kentucky, United States
University of Texas Southwestern Medical Center Dallas
🇺🇸Dallas, Texas, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Coastal Children's Services
🇺🇸Wilmington, North Carolina, United States
The Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Duke University Health System
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States