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

NCT ID: NCT03425110

Last Updated: 2018-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-21

Study Completion Date

2018-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Modified Ketogenic Diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Birmingham and Solihull Mental Health NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manny Bagary, Dr

Role: STUDY_DIRECTOR

Consultant Epileptologist and Neuropsychiatrist

Locations

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Complex Epilepsy Service, The Barberry, BSMHFT

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Manny Bagary, Dr

Role: CONTACT

BSMHFT MKD Service

Role: CONTACT

Facility Contacts

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MKD Service

Role: primary

0121 301 2426

Other Identifiers

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173471

Identifier Type: -

Identifier Source: org_study_id

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