Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02261753
• Date of registration: 26/09/2014
• Prospective Registration: Yes
• Primary sponsor: University College, London
• Public title: Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy EDIBLE
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02261753
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Belgium, Czech Republic, Czechia, France, Germany, Italy, Switzerland, United Kingdom, United States

Contacts

• Name: J Helen Cross, MB ChB PhD
• Affiliation: UCL-London

Key inclusion & exclusion 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.



Age minimum: 3 Years
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cortical Dysplasia

Intervention(s)

Dietary Supplement: Classical ketogenic diet

Primary Outcome(s)

Time to 6 month remission [Time Frame: Month 33]

Secondary Outcome(s)

Time to first seizure from date of randomisation; [Time Frame: 33 months]

Compare the general AE occurrence [Time Frame: 60 months]

Quality of life at 12 (and at 24 months if enough time for follow-up is available) [Time Frame: 45 months]

Time to 12 month remission after randomisation [Time Frame: 45 months]

Time to 24 month remission after randomisation (if enough time for follow-up is available) [Time Frame: 45 months]

Adaptive behaviour assessment at 12 months, after randomisation (and at 24 months if enough time for follow-up is available); [Time Frame: 45 months]

Changes in peripheral DNA (blood platelets) following treatment with the KD [Time Frame: 60 months]

Methylation changes in tissue (DNA) from children pre-treated with the ketogenic diet compared to those not pretreated [Time Frame: 60 months]

Proportion of immediate AEs following resective surgery (i.e. surgical complications within 30 days) [Time Frame: 45 months]

Secondary ID(s)

13/0688

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Liverpool