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Clinical Trials/NCT03425110
NCT03425110
Unknown
Not Applicable

The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study

Birmingham and Solihull Mental Health NHS Foundation Trust1 site in 1 country30 target enrollmentJuly 21, 2015
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Birmingham and Solihull Mental Health NHS Foundation Trust
Enrollment
30
Locations
1
Primary Endpoint
50% responder rate
Last Updated
8 years ago

Overview

Brief Summary

The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study

Detailed Description

Epilepsy is a common neurological condition. Unfortunately, just over 30% of patients with epilepsy (PWE) do not become seizure free with anti-epileptic drugs. Some patients may be suitable for epilepsy surgery. Alternative established treatments include vagal nerve stimulation and the ketogenic diet in children. The evidence base for the use of ketogenic diet in adults is limited. There are a few prospective studies and no randomised control trial to date. This study is a prospective observational cohort study for adult patients with drug resistant epilepsy who are not suitable for resective epilepsy surgery. The intervention is a modified ketogenic diet. The carbohydrate load will be between 20-30gm per day. Blood ketones and blood sugars will be monitored. The primary outcome measure is seizure frequency at 12 months. There are a number of secondary outcome measures including tolerability, seizure severity, quality of life, lipid profiles and health care utilisation.

Registry
clinicaltrials.gov
Start Date
July 21, 2015
End Date
September 1, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

50% responder rate

Time Frame: Twelve months

Study Sites (1)

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