Refractory Status Epilepticus Treatment Study

Non-convulsive Status Epilepticus Clinical Trial

Official title: Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility

Status Completed

Clinical Trial Summary

Identify the most effective dose of valproic acid when used in combination with phenytoin for treatment of patients with refractory status epilepticus, which allow a better clinical course and prognosis of the disease.

Clinical Trial Description

Phase III Clinical trial, to identify the most effective dose of valproic acid (20mg/kg bolus, 1mg/kg/h maintenance vs 40mg/kg bolus, 2mg/kg/h maintenance) in combination with phenytoin, in patients with refractory status epilepticus.

Multicenter clinical trial, single-blind, prospective, randomized 1:1 assignment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Grand Mal Status Epilepticus
• Non-convulsive Status Epilepticus
• Status Epilepticus

• NCT number: NCT01586208
• Study type: Interventional
• Source: Hospital Universitari de Bellvitge
• Status: Completed
• Phase: Phase 3
• Start date: January 2010
• Completion date: October 2012