Status:
TERMINATED
Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy
Lead Sponsor:
University College, London
Collaborating Sponsors:
University of Liverpool
Conditions:
Cortical Dysplasia
Eligibility:
All Genders
3-15 years
Phase:
NA
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 ...
Detailed Description
Epilepsy surgery is now an accepted and effective management for individuals with drug resistant focal onset epilepsy in carefully selected candidates. This aside, only two RCTs have been performed in...
Eligibility Criteria
Inclusion
- Children aged 3 - 15 years;
- MRI changes consistent with a diagnosis of FCD type II a or b;
- History of at least two epileptic seizures in the past 6 months before randomisation;
- Seizure semiology consistent with focal onset, agreed after pre-surgical discussion to be surgically treatable;
- Parent/ legal representative willing to give consent.
Exclusion
- Previous use of the KD;
- Not a surgical candidate for FCD resection;
- Administration of the KD is medically contraindicated.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2017
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02261753
Start Date
October 1 2014
End Date
July 26 2017
Last Update
September 25 2017
Active Locations (15)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21218
2
Medical University Vienna
Vienna, Austria
3
Motol University Hospital
Prague, Czechia
4
Hospices Civil De Lyon
Lyon, France, 69500