Efficacy of Intravenous Levetiracetam in Neonatal Seizures — NEOLEV2  

Neonatal Seizures Clinical Trial

Official title: Efficacy of Intravenous Levetiracetam in Neonatal Seizures: A Phase 2 Randomized Blinded Controlled Study of the Efficacy of Intravenous Levetiracetam (LEV) as First Line Treatment for Neonatal Seizures

Status Completed

Clinical Trial Summary

A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory.

Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.

Clinical Trial Description

This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects.

Levetiracetam (LEV) has great potential as a treatment for neonatal seizures but is not approved for use in children less than 2 years of age.

This study aims to obtain essential data regarding the efficacy and safety of LEV in this vulnerable and under researched population and simultaneously to develop EEG monitoring systems that facilitate seizure detection and research.

Specific aims are:

1. To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy.

2. To obtain dose escalation data by studying the additional efficacy of a further dose in non responders.

3. To obtain additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study.

4. To obtain further safety data of LEV in neonates.

5. To prove the feasibility of centralized remote monitoring of continuous EEG monitoring in the Neonatal Intensive Care Unit (NICU) via the internet and test a promising automated neonatal seizure detection algorithm.

The study design is a phase 2b randomized blinded controlled study. ;

Related Conditions & MeSH terms

• Neonatal Seizures
• Seizures

• NCT number: NCT01720667
• Study type: Interventional
• Source: University of California, San Diego
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2013
• Completion date: July 31, 2019