drugset / Trial / NCT07046611

Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children

NCT07046611

Phase 2/3 Recruiting 124 enrolled Sohag University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

About 40% of children with generalized convulsive status epilepticus (GCSE) are not terminated by first-line benzodiazepines (BDZs), and approximately 50% of BDZ-refractory GCSE are not controlled by second-line antiseizure medications. This study investigates the efficacy of ketamine-levetiracetam combination vs. levetiracetam alone for treating children with BDZ-refractory GCSE.

Timeline

Start
2025-07-02
Primary completion
2026-06-30
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 2 mg/kg Intravenous
Subject Levetiracetam Other / unclassified 60 mg/kg Intravenous