EcLiPSE Version 1.0
Research type
Research Study
Full title
Emergency Treatment with Levetiracetam or Phenytoin in Status Epilepticus in Children (EcLiPSE) – an open label randomised controlled trial
IRAS ID
162325
Contact name
Richard Appleton
Contact email
Eudract number
2014-002188-13
ISRCTN Number
ISRCTN22567894
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
This trial is a two arm, multi-centre parallel group, randomised controlled, open label trial comparing intravenous levetiracetam to intravenous phenytoin for the treatment of convulsive status epilepticus (CSE) in children, young people and young adults. The trial will run in emergency depatments in NHS secondary and tertiary hospitals in the UK, a total of 308 participants will be recruited and total study duration for each participant will be 24 hours.
The Consent study will run alongside EcLiPSE and will involve parents who have been approached about the study and EcLiPSE recruiters. The study will examine approaches to recruitment and deferred consent and explore the views of parents with the aim of identifying recruitment and consent issues and potential solutions to inform EcLiPSE recruiter training materials.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0090
Date of REC Opinion
3 Mar 2015
REC opinion
Further Information Favourable Opinion