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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03425110
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Birmingham and Solihull Mental Health NHS Foundation Trust

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

Condition or disease Intervention/treatment
Epilepsy Other: Modified Ketogenic Diet

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.


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study
Actual Study Start Date : July 21, 2015
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources




Primary Outcome Measures :
  1. 50% responder rate [ Time Frame: Twelve months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult outpatients with pharmacoresistant epilepsy referred to and accepted by the epilepsy clinic will be eligible to participate.
Criteria
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425110


Contacts
Contact: Manny Bagary, Dr m.bagary@nhs.net
Contact: BSMHFT MKD Service bsmhft.modifiedketogenicdiet@nhs.net

Locations
United Kingdom
Complex Epilepsy Service, The Barberry, BSMHFT Recruiting
Birmingham, West Midlands, United Kingdom, B15 2FG
Contact: MKD Service    0121 301 2426    bsmhft.modifiedketogenicdiet@nhs.net   
Sponsors and Collaborators
Birmingham and Solihull Mental Health NHS Foundation Trust
Investigators
Study Director: Manny Bagary, Dr Consultant Epileptologist and Neuropsychiatrist

Responsible Party: Birmingham and Solihull Mental Health NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03425110     History of Changes
Other Study ID Numbers: 173471
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases