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Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy

NCT02261753 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-09-25

No results posted yet for this study

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.

Conditions

  • Cortical Dysplasia

Interventions

DIETARY_SUPPLEMENT

Classical ketogenic diet

A high fat low carbohydrate, low protein diet.

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • J Helen Cross, MB ChB PhD · UCL-London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-07-26
Completion
2017-07-26

Countries

  • United States
  • Austria
  • Czechia
  • France
  • Germany
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261753 on ClinicalTrials.gov