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NCT03425110 Clinical Trial

The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03425110
Other study ID # 173471
Secondary ID
Status Recruiting
Phase N/A
First received February 1, 2018
Last updated February 8, 2018
Start date July 21, 2015
Est. completion date September 1, 2018

Study information
Verified date February 2018
Source Birmingham and Solihull Mental Health NHS Foundation Trust
Contact Manny Bagary, Dr
Email m.bagary@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date September 1, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility The study will have no formal inclusion/exclusion criteria as it is purely observational and it will be the clinical team's decision as to whether or not people are seen by the dietary clinic based on established dietary clinic protocols.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Modified Ketogenic Diet

Locations
Country Name City State
United Kingdom Complex Epilepsy Service, The Barberry, BSMHFT Birmingham West Midlands

Sponsors (1)
Lead Sponsor Collaborator
Birmingham and Solihull Mental Health NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 50% responder rate Twelve months
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