Lab Data Upload in Pharmacokinetics of Anti-epileptic Drugs in Obese Children - Oxcarbazepine

Lab Data Upload (Specimen Concentration Results)
Study Description
This was a multi-center, prospective, open-label, pharmacokinetic (PK) and safety study of anti-epileptic drugs in obese children age 2 to less than 18 years of age who received drugs per standard of care (SOC), as prescribed by a treating clinician. Participants were enrolled under multiple drugs of interest, including oxcarbazepine. Simulations from the PK models revealed that the currently recommended dosing regimen of oxcarbazepine produced equivalent steady state exposure of its active metabolite between children with and without obesity from 2 to 20 years of age. Therefore, the current population PK analysis confirms the applicability of the currently recommended dosing regimen of oxcarbazepine in children with obesity. No adverse events were reported in the oxcarbazepine participants, and no safety concerns were identified in this SOC study. Participants who received oxcarbazepine and were included in the safety population.