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

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, as prescribed by a treating clinician. Participants were enrolled under multiple drugs of interest, including levetiracetam. The PK of levetiracetam in children was well characterized with a 1-compartment population PK model. After accounting for size-based differences using fat free mass, estimated glomerular filtration rate was associated with clearance of levetiracetam. A weight-based dosing regimen was recommended for levetiracetam oral solution dosing in 2 to <4 years. Weight-tiered dosing regimens were recommended for levetiracetam oral solution dosing and tablet dosing in obese participants 4 to <16 years. Levetiracetam was well tolerated in the study participants. Participants who received levetiracetam and were included in the safety population.