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

NCT02229123 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • Neonatal Seizures

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Rennes University Hospital

    collaborator OTHER

  • Amiens University Hospital

    collaborator OTHER

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Geraldine Favrais, Dr · University Hospital of Tours

  • Geraldine FAVRAIS, Dr · University hospital of Tours

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
36 Weeks
Max Age
43 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2022-02-23
Completion
2022-02-23

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229123 on ClinicalTrials.gov