Emergency treatment with levetiracetam or phenytoin in status epilepticus

Plain English Summary

Background and study aims
Most epileptic seizures and convulsions in children last less than three minutes and will stop on their own accord. However, on occasion, a seizure may continue for longer than three minutes and eventually become what is called convulsive status epilepticus (CSE). This is a medical emergency. To prevent CSE from happening, children are given an antiepileptic medicine called an emergency or rescue medicine (also known as first-line treatment). However, this treatment will only be successful in around half of all children. In those cases where the rescue medicine is not successful, the children need to be taken to the Accident and Emergency Department (AED) of their local hospital. Once there, if the child is still in the seizure, they are given a different rescue medicine. This again will be successful in stopping the seizure in about half of the children. For those that are still in seizure, a different medicine is then given (this medicine is known as second-line treatment). The usual medicine given at this stage is called phenytoin. However, again it only has an about 50% success rate and has to be given very carefully because it can cause very unpleasant and very serious side-effects, including those that may affect the heart, blood pressure and skin. Some early results of a new anticonvulsant called levetiracetam suggest that this medicine may work better and be safer than phenytoin. The aim of this study is to find out whether this is really the case.

Who can participate?
Children between 6 months and 18 years of age in CSE which has not stopped after being given first-line treatment.

What does the study involve?
The children are randomly allocated into one of two groups. Those in group 1 are given intravenous levetiracetam. Those in group 2 are given intravenous phenytoin. The children's progress is then followed for 24 hours. We want to see how long it takes for the seizure to stop after the drugs have been given, whether any further medicine has to be given, whether the child needs to go the intensive care unit, and whether the child develops any unwanted side-effects. Added 17/11/2017: We also now complete a 14 day follow up to see how the children who have taken part are at 14 days after treatment.

What are the possible benefits and risks of participating?
Phenytoin will only stop CSE is about 50-60% of cases and has to be given slowly to avoid a drop in blood pressure and irregular heart beat (cardiac arrhythmias). It may also cause irritation of the veins and inflammation. Levetiracetam may stop CSE in more than 70% of cases. Risks of taking levetiracetam may include dizziness, feeling sleepy and headache. Added 17/11/2017: Levetiracetam side effects can also include: Agitation or a skin reaction including swelling of the tongue and lips and/or a red itchy rash.

Where is the study run from?
Institute of Child Health, Alder Hey Children's NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2014 to September 2018

Who is funding the study?
National Institute for Health Research HTA (UK)

Who is the main contact?
Ms Amy Humphreys
eclipse.trial@liverpool.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Liverpool (UK) and Alder Hey Children's NHS Foundation Trust
University/education

c/o Ms Karen Wilding
Research Integrity and Governance Manager
Research Support Office
University of Liverpool / Liverpool Joint Research Office
2nd Floor Block D Waterhouse Building
3 Brownlow Street
c/o Lucy Cooper
Research Governance and Quality Assurance Lead
Clinical Research Business Unit
2nd Floor, Institute in the Park
Alder Hey NHS Foundation trust
Eaton Road
Liverpool
L12 2AP
England
United Kingdom

"ROR"	https://ror.org/00p18zw56

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

17/11/2020: Publication reference added.
23/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added from the results publication.
30/04/2018: The recruitment end date has been changed from 01/03/2018 to 10/04/2018.
17/11/2017: The overall trial dates have been updated from 01/03/2015-31/05/2018 to 01/04/2014-01/09/2018. The recruitment dates have been updated from 01/03/2015-01/06/2018 to 15/07/2017-01/03/2018. Publication and dissemination plans have been added. Participant level data has been added. Plain English summary has been updated. Arrow Park Hospital has been removed as a trial participating site. The following hospitals have been added: Addenbrooke's Hospital, Great North Children's Hospital, James Cook University Hospital, Leeds General Infirmary, Royal Belfast Hospital for Sick Children, Royal London Hospital, University Hospital Lewisham, University Hospital of Wales, Cardiff, Watford General Hospital and Western Sussex Hospitals NHS Foundation Trust. Sponsor information has been added to include Lucy Cooper Alder Hey NHS Foundation Trust.
22/06/2017: Publication reference added.
09/04/2015: The following changes were made to the trial record:
1. The scientific title was changed from 'Emergency Treatment with Levetiracetam or Phenytoin in Status Epilepticus in Children (EcLiPSE) - a randomised unblinded controlled trial' to 'Emergency Treatment with Levetiracetam or Phenytoin in Status Epilepticus in Children (EcLiPSE) – an open-label randomised controlled trial'.
2. The target number of participants was changed from 340 to 308.