Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy

Stopped early · Not applicable

Conditions studied: Cortical Dysplasia

In brief

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.

Key facts

Study ID

NCT02261753

Run by

University College, London

People needed

3

Starts

2014-10-01

Expected to finish

2017-07-26

Last updated by the study team

2017-09-25

Who can join

Age: 3 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Previous use of the KD;
• Not a surgical candidate for FCD resection;
• Administration of the KD is medically contraindicated.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Medical University Vienna — Vienna, Austria
• Motol University Hospital — Prague, Czechia
• Hospices Civil De Lyon — Lyon, France
• Hopital de Hautepierre — Strasbourg, France
• Krakenhaus Mara Maraweg — Bielefeld, Germany
• Schpn Klinik Vogtareuth — Vogtareuth, Germany
• Childrens Hospital Meyer — Florence, Italy
• Ospedale Pediatric Bambino Gesu — Rome, Italy
• Hopitaux Universitaires de Geneve — Geneva, Switzerland
• Birmingham Childrens Hospital — Birmingham, United Kingdom
• Bristol Childrens Hospital — Bristol, United Kingdom
• Royal Hospital for Sick Children — Edinburgh, United Kingdom
• Great Ormond Street Hospital for Children NHS Trust — London, United Kingdom
• Manchester Childrens Hospital — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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