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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
Sponsor:
Collaborator:
University of Liverpool
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:
The investigators are undertaking the first European Randomised Controlled Trial (RCT) for epilepsy surgery in children with FCD type II, to prospectively evaluate the role of the KD prior to surgery in improving seizure outcome. The investigators will evaluate the role of KD as a disease-modifying treatment to achieve seizure control and improve neurodevelopment and quality of life. Children age 3 - 15 years with pharmacoresistant epilepsy believed to be the result of focal cortical dysplasia type II, considered to be surgically treatable, will be randomised to either receive 6m treatment presurgery with a ketogenic diet, or to proceed direct to surgery (no pretreatment). Primary outcome will be the time to achieve a period of 6 months of seizure freedom from the date of randomisation. Tissue resected at surgery will also be evaluated with regard to the degree of any methylation of DNA.

Condition or disease Intervention/treatment Phase
Cortical Dysplasia Dietary Supplement: Classical ketogenic diet Not Applicable

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Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Changes in peripheral DNA (blood platelets) following treatment with the KD [ Time Frame: 60 months ]
    As measured from samples taken following the KD

  8. 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

  9. Compare the general AE occurrence [ Time Frame: 60 months ]
    As compared between groups, group pre-treated with KD compared to those without


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children aged 3 - 15 years;
  2. MRI changes consistent with a diagnosis of FCD type II a or b;
  3. History of at least two epileptic seizures in the past 6 months before randomisation;
  4. Seizure semiology consistent with focal onset, agreed after pre-surgical discussion to be surgically treatable;
  5. Parent/ legal representative willing to give consent.

Exclusion Criteria:

  1. Previous use of the KD;
  2. Not a surgical candidate for FCD resection;
  3. Administration of the KD is medically contraindicated.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
University College, London
University of Liverpool
Investigators
Principal Investigator: J Helen Cross, MB ChB PhD UCL-London
More Information
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Publications:

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02261753     History of Changes
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

Keywords provided by University College, London:
epilepsy surgery, outcome, ketogenic diet, ortical dysplasia

Additional relevant MeSH terms:
Epilepsy
Malformations of Cortical Development
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Nervous System Malformations
Congenital Abnormalities