Phase IIb Study to Find the Safest High Dose of Levetiracetam for Treating Seizures in Newborns

What this Trial Is About

Researchers are evaluating the maximum safe and tolerated dose of Levetiracetam LEV for treating neonatal seizures. This Phase IIb, open-label dose-escalation study aims to determine if higher doses of LEV than currently used can improve seizure control in newborns. The study includes infants at risk or confirmed to have neonatal seizures of mild to moderate severity, with continuous video EEG monitoring used to assess seizure activity and control. Participants initially receive a 60 mgkg dose of LEV. If seizures persist after this dose, they are randomized to either receive higher doses of LEV 90 mgkg, 120 mgkg, or 180 mgkg in increments or treatment with Phenobarbital PHB at 20-40 mgkg. Maintenance treatment with PHB may continue for five days either intravenously or orally if tolerated. The study includes three phases, with Phase 3 expanding to neonates with more severe seizure burden if earlier phases show efficacy. Throughout the study, participants are monitored with continuous EEG reviewed by neurophysiologists to assess seizure control over 24 hours and changes in seizure burden during the two hours after treatment. Safety, pharmacokinetics, seizure freedom rates, adverse events, and long-term outcomes up to eight years are evaluated. The study also assesses new technology for neonatal seizure detection. Participation may last several years due to extended follow-up for long-term outcomes.

A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures