Protocol Deviation in Pharmacokinetics of Anti-epileptic Drugs in Obese Children - Oxcarbazepine

Protocol Deviation Information
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.

方案偏离信息
研究概况
本研究为一项多中心、前瞻性、开放标签的药代动力学（pharmacokinetic, PK）与安全性研究，针对2岁至未满18岁的肥胖儿童，受试儿童均接受经治疗医师开具的标准治疗（standard of care, SOC）方案给药，研究药物为抗癫痫药物。本研究纳入同时接受多种目标药物治疗的受试者，其中包含奥卡西平（oxcarbazepine）。
药代动力学模型的模拟结果显示，针对2至20岁年龄段的儿童，当前推荐的奥卡西平给药方案，其活性代谢物的稳态暴露量在肥胖与非肥胖儿童间无显著差异。据此，本次群体药代动力学分析证实，当前推荐的奥卡西平给药方案可应用于肥胖儿童群体。
本研究中接受奥卡西平治疗的受试者未报告任何不良事件，本次标准治疗研究亦未发现任何安全性隐患。本研究的安全性分析人群由所有接受奥卡西平治疗的受试者组成。