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Clinical Trials/ISRCTN41638605
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.

Registry
who.int
Start Date
November 13, 2014
End Date
July 26, 2017
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London (UK)

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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