Levetiracetam is an adjunctive treatment for partial-onset seizures in patients with epilepsy aged 4 years and older. An IV formulation was developed as an alternative for patients who are temporarily unable to receive the oral therapy. While IV levetiracetam concentrations were previously investigated in healthy adults, this trial was designed to assess the risk of excessive plasma concentrations in children age 4 to 17 years.

Lead investigator, Eric Snoeck, PhD, director and a founder of pharmaceutical-development consulting company Exprimo, Lummen, Belgium, said a 2-compartment pharmacokinetic model developed for adults was combined with an existing population pharmacokinetic model of oral levetiracetam in children to simulate plasma concentrations following IV infusion.

In the study, twice daily IV levetiracetam schemes were simulated (2000 times) for typical children and adults, with infusions lasting 15, 30 and 60 minutes simulated every 12 hours for 7 days (steady state conditions). Twice daily oral dosing was also simulated, as a reference.

The researchers determined simulated steady state concentrations and exposure after 30 mg/kg twice daily in children and 1500 mg twice daily in adults (both IV and oral). All results were within predicted and observed ranges at the end of 15-minute IV infusions, leading the researchers to conclude that there is no need to recommend a different infusion duration in children than in adults, the researchers said.


[Presentation title: Levetiracetam Intravenous Infusion: Simulation of Plasma Profiles in Children to Evaluate Dose Adaptation Rules. Abstract 44]

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