Pharmacokinetics of Anti-epileptic Drugs in Obese Children

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).