Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy (EDIBLE)
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ClinicalTrials.gov Identifier: NCT02261753 |
Recruitment Status :
Terminated
(The study oversight committees unanimously decided to stop the study early on 26/07/2017 due to poor recruitment.)
First Posted : October 10, 2014
Last Update Posted : September 25, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cortical Dysplasia | Dietary Supplement: Classical ketogenic diet | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomised Controlled Trial to Compare Seizure Remission Outcome Following Resective Surgery With or Without Prior Treatment With Ketogenic Diet in Children With Epilepsy the Result of Focal Cortical Dysplasia Type II |
Study Start Date : | October 2014 |
Actual Primary Completion Date : | July 26, 2017 |
Actual Study Completion Date : | July 26, 2017 |

Arm | Intervention/treatment |
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Active Comparator: A: Classical ketogenic diet
The KD is a high fat, low carbohydrate, low protein diet designed to mimic the effects of fasting on the body. It will be administered by calculation as per local standardised classical KD protocol with utilisation of long chain fat in a ratio of 2:1 to 4:1 carbohydrate and protein.
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Dietary Supplement: Classical ketogenic diet
A high fat low carbohydrate, low protein diet. |
No Intervention: B: No pretreatment
Following the decision to proceed to surgery, if randomised to this arm a date will be given for surgery as per routine clinical practice. No KD pre-treatment will be undertaken.
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- Time to 6 month remission [ Time Frame: Month 33 ]the time to achieve a period of 6 months of seizure freedom from the date of randomisation pretreated KD group vs non pretreated group
- Time to first seizure from date of randomisation; [ Time Frame: 33 months ]The time to first seizure from date of randomisation, KD pretreated vs non pretreated group
- Time to 12 month remission after randomisation [ Time Frame: 45 months ]Time to 12 month remission from seizures from date of randomisation, KD pretreated vs non pretreated group
- Time to 24 month remission after randomisation (if enough time for follow-up is available) [ Time Frame: 45 months ]Time to 24 months remission from seizures from date of randomisation, KD pretreated vs non pretreated group
- Quality of life at 12 (and at 24 months if enough time for follow-up is available) [ Time Frame: 45 months ]As determined by KINDL questionnaire, comparison of pretreated vs non pretreated group
- Adaptive behaviour assessment at 12 months, after randomisation (and at 24 months if enough time for follow-up is available); [ Time Frame: 45 months ]Comparison of neurodevelopmental change between pretreated and non pretreated KD group, as measured by Vineland adaptive behaviour scales
- Methylation changes in tissue (DNA) from children pre-treated with the ketogenic diet compared to those not pretreated [ Time Frame: 60 months ]As measured from tissue resected at surgery
- Changes in peripheral DNA (blood platelets) following treatment with the KD [ Time Frame: 60 months ]As measured from samples taken following the KD
- Proportion of immediate AEs following resective surgery (i.e. surgical complications within 30 days) [ Time Frame: 45 months ]As compared between groups, group pre-treated with KD compared to those without
- Compare the general AE occurrence [ Time Frame: 60 months ]As compared between groups, group pre-treated with KD compared to those without

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Ages Eligible for Study: | 3 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children aged 3 - 15 years;
- MRI changes consistent with a diagnosis of FCD type II a or b;
- History of at least two epileptic seizures in the past 6 months before randomisation;
- Seizure semiology consistent with focal onset, agreed after pre-surgical discussion to be surgically treatable;
- Parent/ legal representative willing to give consent.
Exclusion Criteria:
- Previous use of the KD;
- Not a surgical candidate for FCD resection;
- Administration of the KD is medically contraindicated.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261753
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21218 | |
Austria | |
Medical University Vienna | |
Vienna, Austria | |
Czechia | |
Motol University Hospital | |
Prague, Czechia | |
France | |
Hospices Civil De Lyon | |
Lyon, France, 69500 | |
Hopital de Hautepierre | |
Strasbourg, France, 67098 | |
Germany | |
Krakenhaus Mara Maraweg | |
Bielefeld, Germany, 33617 | |
Schpn Klinik Vogtareuth | |
Vogtareuth, Germany, 83569 | |
Italy | |
Childrens Hospital Meyer | |
Florence, Italy, 50139 | |
Ospedale Pediatric Bambino Gesu | |
Rome, Italy, 00165 | |
Switzerland | |
Hopitaux Universitaires de Geneve | |
Geneva, Switzerland, CH-1211 | |
United Kingdom | |
Birmingham Childrens Hospital | |
Birmingham, United Kingdom, B4 6NH | |
Bristol Childrens Hospital | |
Bristol, United Kingdom, BS2 8AE | |
Royal Hospital for Sick Children | |
Edinburgh, United Kingdom, EH9 1LF | |
Great Ormond Street Hospital for Children NHS Trust | |
London, United Kingdom, WC1N 3JH | |
Manchester Childrens Hospital | |
Manchester, United Kingdom, M27 4HA |
Principal Investigator: | J Helen Cross, MB ChB PhD | UCL-London |
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT02261753 |
Other Study ID Numbers: |
13/0688 |
First Posted: | October 10, 2014 Key Record Dates |
Last Update Posted: | September 25, 2017 |
Last Verified: | October 2014 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
epilepsy surgery, outcome, ketogenic diet, ortical dysplasia |
Epilepsy Malformations of Cortical Development Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Nervous System Malformations Congenital Abnormalities |