Efficacy of Combined Ketamine and Levetiracetam as a Second-line Anti-seizure Medication for Generalized Convulsive Status Epilepticus in Children

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 16
Healthy Volunteers: f
View:

• Age from 1 year to 16 years.

• Generalized convulsive status epilepticus (GCSE), defined as clinically observed generalized tonic-clonic convulsions that continue or recur without complete regaining of consciousness in between for longer than 5 minutes.

• Benzodiazepine-refractory, defined as continuous or recurrent GCSE in the emergency room after receiving an adequate benzodiazepine dose, with the last dose administered within 5 to 30 minutes.

Locations
Other Locations
Egypt
Department of Pediatrics at Sohag University Hospital
RECRUITING
Sohag
Contact Information
Primary
Elsayed Abdelkreem, MD, PhD
d.elsayedmohammed@med.sohag.edu.eg
1114232126
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 124
Treatments
Experimental: Ketamine + Levetiracetam
Placebo_comparator: Placebo + Levetiracetam
Related Therapeutic Areas
Sponsors
Leads: Sohag University

This content was sourced from clinicaltrials.gov