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NCT02261753 · ClinicalTrials.gov registry record · NA
Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy
A NA study, sponsored by University College, London.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT02261753 is a NA study that was terminated before completion, run by University College, London. The registered enrollment target is 3 participants.
The verdict
NCT02261753, a NA study, was terminated before completion, sponsored by University College, London.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
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.
Interventions
- DIETARY_SUPPLEMENT Classical ketogenic diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-10 |
| Est. Completion | 2017-07-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02261753
The ClinicalTrials.gov registry entry for NCT02261753 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University College, London, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Classical ketogenic diet is the first listed.
NCT02261753 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02261753 about?
NCT02261753 is a clinical study titled "Evaluating Dietary Intervention Before surgicaL Treatment for Epilepsy". 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 ...
What is the current status of trial NCT02261753?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2014-10. Estimated completion is 2017-07-26.
What interventions are being tested in trial NCT02261753?
The interventions under investigation include: Classical ketogenic diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02261753?
This trial is sponsored by University College, London, which has 8 total clinical trials registered on ClinicalTrials.gov.
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