Pharmacokinetics of Anti-epileptic Drugs in Obese Children (AED)

Studying the pharmacokinetics of anti-seizure medications (levetiracetum, valproic acid, topiramate, and oxcarbazepine) in obese children to inform dosing guidelines.

Summary

Childhood obesity has increased over the last decade. Due to altered pharmacokinetics (PK) associated with obesity, dosing for anti-epileptics in obese children may vary from that in non-obese children.  Inappropriate dosing may increase the risk for drug toxicity or therapeutic failure.  PK studies are urgently needed to determine appropriate dosing strategies for anti-epileptics in obese children.

The Pharmacokinetics of Anti-epileptic Drugs in Obese Children (AED) study will enroll approximately 100 children, 2 to < 18 years of age, with a body mass index (BMI) > 95th percentile, who are receiving levetiracetum, valproic acid, topiramate, or oxcarbazepine, per standard of care.  Enrollment will begin in the second quarter of 2016 at up to 10 US sites.  Results from the study are expected by early 2017—soon thereafter, the study team hopes to submit dosing guidelines to the FDA.

OVERVIEW

Status:
Enrollment to begin second quarter 2016

ClinicalTrials.gov identifier: Pending

Principal Investigator:
Kanecia Zimmerman, MD, MPH
Duke Health, Durham, NC

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