Vital Signs in Pharmacokinetics of Anti-epileptic Drugs in Obese Children - Topiramate

Vital Signs 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 topiramate. Simulation results (with the currently recommended dosing regimens) did not reveal any meaningful difference in the steady-state topiramate trough concentrations between the subgroups of children with and without obesity, across the major pediatric age groups. Therefore, the currently recommended dosing regimen of topiramate can be universally applied to children, irrespective of their obesity status. No AEs were reported in topiramate participants, and no safety concerns were identified in this SOC study. Participants who received topiramate and were included in the safety population.