Epilepsy, Obese
Conditions
Keywords
Epilepsy, Obese
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).
Interventions
OTHERAnti-epileptics
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Christoph P Hornik, MD MPH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Known pregnancy as determined via interview or test results, if available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steady-state pharmacokinetics absorption rate constant | Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) |
| 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) |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse events | Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) |
Countries
United States
Outcome results
None listed