Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study — LEVNEONAT-1  

Neonatal Seizures Clinical Trial

Official title: Levetiracetam Efficacy and Safety as First-line Treatment of Neonatal Seizures Occuring in Hypoxic-ischemic Encephalopathy Context

Status Completed

Clinical Trial Summary

LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam as first line treatment in term newborn babies with seizures in hypoxic-ischemic encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures in newborns.

Clinical Trial Description

Article Focus

• The principal aim of LEVNEONAT-1 is to determine the levetiracetam optimal dose defined as the highest efficient dose under toxicity restrictions for treating neonatal seizures.

• LEVNEONAT-1 is an open-label, sequential dose-finding study with 3 increasing dose levels of levetiracetam.

Strenghts and limitation of study

• For the first time, levetiracetam will be used as the first-line treatment of neonatal seizures and not as an add-on therapy.

• Statistical model is designed for a rare clinical situation with a sequential adaptive method updating in real time the dose allocation for next patient by using all available data from previous participants.

• The targeted population, i.e. the newborn less than 3 days of life, is particularly sensitive and the written consent of both parents is required before the levetiracetam administration. ;

Related Conditions & MeSH terms

• Hypoxia-Ischemia, Brain
• Neonatal Seizures
• Seizures

• NCT number: NCT02229123
• Study type: Interventional
• Source: University Hospital, Tours
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2018
• Completion date: February 23, 2022