Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Study Overview
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Brief Summary
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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).

Official Title
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Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Conditions
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Epilepsy, Obese

Intervention / Treatment
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* Other: Anti-epileptics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Levetiracetam<br>Children with epilepsy who are treated with levetiracetam per local standard of care | Other: Anti-epileptics<br> <br> |
| Valproic Acid<br>Children with epilepsy who are treated with valproic acid per local standard of care | Other: Anti-epileptics<br> <br> |
| Topiramate<br>Children with epilepsy who are treated with topiramate per local standard of care | Other: Anti-epileptics<br> <br> |
| Oxcarbazepine<br>Children with epilepsy who are treated with oxcarbazepine per local standard of care | Other: Anti-epileptics<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events |  | Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Obese