drugset / Trial / NCT01239212

Dosing of Levetiracetam (Keppra) in Neonates

NCT01239212

Phase 1/2 Completed 7 enrolled Children's Hospital Medical Center, Cincinnati
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.

Timeline

Start
2010-09
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 50 mg/kg Intravenous

Indications