Overview

Welcome to the EDIBLE research study website. EDIBLE is an interventional clinical trial in 120 children and adolescents with epilepsy due to Focal Cortical Dysplasia (FCD) type II.

E-Mail:  Edible.Study@liverpool.ac.uk

Study Closed

The EDIBLE study has now stopped recruiting new participants. The Independent Data Safety and Monitoring Committee and the Trial Steering Committee reviewed the progress of the study and decided that because of the very low patient recruitment numbers the study should end (close) prematurely. This mean no further patient should be included in the study and any patients already taking part will not be followed-up further or undergo any further procedures (i.e. ketogenic diet and/or surgery) unless this is in their best care. Blood/tissue material from surgery can be sent to the Biobank, where the patient has indicated willingness to do so after being informed the study has closed.

The standard treatment for children and adolescents with difficult to treat epilepsy is resective surgery. The EDIBLE study will investigate the role and possible benefits of a ketogenic diet taken for six months before resective surgery, on seizure outcome and other factors. The ketogenic diet is a high fat – low carbohydrate diet that must be calculated and managed by an experienced dietitian. To find out more about the EDIBLE trial please see the Trial Summary section. EDIBLE is a multi-centre international trial that will take place in several countries across Europe including the United Kingdom, Czech Republic, Germany, Italy, France, Switzerland and Austria and the USA. To find out which centres are taking part in the study please see the Recruiting Centres section.

The EDIBLE study is one part of a collaborative project DESIRE aims to investigate “Development and Epilepsy - Strategies for Innovative Research to improve diagnosis, prevention and treatment in children with difficult to treat Epilepsy”. DESIRE brings together researchers from around Europe with outstanding track record in genetics, basic neurophysiology, neuropathology and clinical research in order to investigate early onset epilepsies relating to developmental brain processes.

Randomised patients

3

Target patients

120

Open sites

8

Target Sites

15

Collaborators

DESIRE img
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The Clinical Trials Research Center

Hospital departments taking part

The study will take part in tertiary paediatric epilepsy centres across Europe. To see if your hospital is taking part in this study please go to recruiting centres.

Study funder

Research for EDIBLE, is funded by the European Union 7th Framework Program under grant agreement no: Health-F2-602531-2013.

Study organiser

University College London, Liverpool University.

Study review and approval

The study has been reviewed by a number of research ethics committees nationally or locally according to each counties regulation. The, research ethics committees agreed the study is being conducted in a correct and appropriate manner

Trial Summary and Frequently Asked Questions

Why are we doing this research study?

The aim of the EDIBLE study is to explore whether administration of a ketogenic diet to children diagnosed with drug-resistant Focal Cortical Dysplasia Type II before surgery will partially rescue seizure-associated gene regulating DNA methylation changes and improve seizure outcome. The EDIBLE study will compare changes in seizures after surgery between children that followed a ketogenic diet or their usual diet before surgery. The study will help us find out if having a ketogenic diet before surgery is any better at stopping seizures than surgery alone. Ultimately, the results of this study may help to optimise future routine treatment for children with epilepsy the result of Focal Cortical Dysplasia Type II

What is being assessed?

The EDIBLE study will primarily assess the time to achieve a period of 6 months of seizure freedom from the date of randomisation. Additionally, the effect of a ketogenic diet on seizures, Quality of Life, adaptive behaviour status and any potential influences on DNA related functions in tissue and blood samples will be examined.

Recruiting Centres

Centre Name

Location

PI Name

Krankenhaus Mara Maraweg

Bielefeld, Germany

Dr Tilman Polster

Birmingham Children’s Hospital

Birmingham, UK

Dr Shakti Agrawal

Bristol Royal Hospital for Children

Bristol, UK

Dr Jayesh Patel

Royal Hospital for Sick Children

Edinburgh, UK

Dr Ailsa McLellan

Children's Hospital Meyer

Florence, Italy

Dr Carmen Barba

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Dr Christian Korff

Great Ormond Street Hospital for Children

London, UK

Dr Sophia Varadkar

HFME – Hospices Civils De Lyon

Lyon, France

Prof Alexis Arzimanoglou

Royal Manchester Children's Hospital

Manchester, UK

Dr Timothy Martland

Motol University Hospital

Prague, Czech Republic

Prof Pavel Krsek

Ospedale Pediatrico Bambino Gesù

Rome, Italy

Dr Nicola Specchio

Hopital de Hautepierre

Strasbourg, France

Dr Anne de Saint Martin

Schön Klinik Vogtareuth

Vogtareuth, Germany

Dr Thomas Herberhold

Medical University Vienna

Vienna, Austria

Prof Martha Feucht

Johns Hopkins Hospital

Baltimore, USA

Prof Eric Kossoff

Contacts

Please feel free to contact the EDIBLE study team by any of the means below:

Telephone


+44 (0) 151 794 9774

Address

Medicines for Children Clinical Trials Unit
Clinical Trials Research Centre
University of Liverpool
Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Liverpool
L12 2AP

 

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The EDIBLE trial is funded by The EU FP7 framework. The information contained in this website is for general information about the EDIBLE trial and is provided by the University of Liverpool Clinical Trials Research Centre. The views expressed are those of the authors and are not intended to be representative of the views of the funder, sponsor or other participating organisations.

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