NCT02229123

Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 36 Weeks – 43 Weeks
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neonatal Seizures

Interventions

Type	Name	Description
DRUG	Intravenous Levetiracetam	Open-study. If seizure lasting more than 3 minutes on EEG recording or brief repeated seizures (more or equal to 2 seizures lasting more than 20 seconds on a 1 hour-interval), the loading-dose of LEV allocated to patient is infused followed by the 8 maintenance dose.

Timeline

• Start date: 2018-02-27
• Primary completion: 2022-02-23
• Completion: 2022-02-23
• First posted: 2014-08-29
• Last updated: 2025-12-30

Locations

8 sites across 1 country: France