Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Christoph P Hornik, MD MPH

Status: Completed

Conditions: Obese; Epilepsy

Treatments: Other: Anti-epileptics

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT02993861

Pro00070924

Details and patient eligibility

About

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).

Enrollment: 106 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

106 participants in 4 patient groups

Levetiracetam

Description:

Children with epilepsy who are treated with levetiracetam per local standard of care

Treatment:

Other: Anti-epileptics

Valproic Acid

Description:

Children with epilepsy who are treated with valproic acid per local standard of care

Treatment:

Other: Anti-epileptics

Topiramate

Description:

Children with epilepsy who are treated with topiramate per local standard of care

Treatment:

Other: Anti-epileptics

Oxcarbazepine

Description:

Children with epilepsy who are treated with oxcarbazepine per local standard of care

Treatment:

Other: Anti-epileptics