ISRCTN41638605
Terminated
未知
Evaluating Dietary Intervention Before surgicaL treatment for Epilepsy (EDIBLE)
niversity College London (UK)0 sites60 target enrollmentNovember 13, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Topic: Children
- Sponsor
- niversity College London (UK)
- Enrollment
- 60
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current as of 19/09/2017:
- •This is applicable to all participating countries with trial approvals working to Protocol V5\.0 06/09/2016 except Austria and Germany (working to Protocol V2\.0 17/03/2015\)
- •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.
- •Previous inclusion criteria:
- •1\. Children aged 5\-15 years
- •2\. MRI changes consistent with a diagnosis of Focal Cortical Dysplasia type II a or b
Exclusion Criteria
- •1\. Previous use of the ketogenic diet
- •2\. Not a surgical candidate for Focal Cortical Dysplasia resection
- •3\. Administration of the ketogenic diet is medically contraindicated
Outcomes
Primary Outcomes
Not specified
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