Study of Adding Two Different Doses of Ketamine to Levetiracetam for Treating Status Epilepticus in Patients Aged 1 Year and Older

What this Trial Is About

Researchers are evaluating if adding ketamine to levetiracetam treatment can better control status epilepticus SE in patients whose seizures do not respond to benzodiazepines. This phase 3, multicenter, randomized, and blinded study compares two doses of ketamine combined with levetiracetam against levetiracetam alone. The study aims to find out which treatment stops SE more effectively and to assess safety, especially in children. Participants are randomly assigned to receive one of three treatments levetiracetam alone at 60 mgkg, levetiracetam plus a low dose of ketamine 1 mgkg, or levetiracetam plus a higher dose of ketamine 3 mgkg. The study drugs are produced centrally and administered via infusion with identical methods to maintain blinding. The trial initially enrolls up to 350 participants evenly across groups before shifting to adaptive randomization, with a total maximum enrollment of 770. During the study, researchers monitor seizure termination starting 15 minutes after infusion and sustained for 60 minutes without additional anti-seizure drugs. They assess consciousness improvement, EEG seizure activity, and safety outcomes including need for intubation, ICU and hospital stay duration, late recurrent seizures, and mortality up to 30 days. Participants undergo close clinical observation and EEG when available to evaluate treatment effects and adverse events throughout the trial period.

Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)