EpilepsyNCT03425110
The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults
An observational study of Epilepsy, run by Birmingham and Solihull Mental Health NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Modified Ketogenic Diet
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jul 2015to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult outpatients with pharmacoresistant epilepsy referred to and accepted by the epilepsy clinic will be eligible to participate.
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.
Trial locations and contacts
1 site in 1 country.
Manny Bagary, Dr contact
BSMHFT MKD Service contact
United Kingdom1 site, 1 recruiting
- Recruiting
Complex Epilepsy Service, The Barberry, BSMHFT
Birmingham, West Midlands, B15 2FG
MKD Service, 0121 301 2426, bsmhft.modifiedketogenicdiet@nhs.net
About this study
Official title: The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study
The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Modified Ketogenic Diet
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Ketogenic DietOther
What is being measured
The primary outcome is the main question the study is designed to answer.
50% responder rate
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start21 Jul 2015
- Primary completion30 Jun 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham and Solihull Mental Health NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manny Bagary, Dr, Study director, Consultant Epileptologist and Neuropsychiatrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425110
- Sponsor's protocol ID
- 173471
- Status last verified
- Feb 2018
- First submitted
- 1 Feb 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03425110
- Acronym / sponsor ID
- 173471
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Birmingham and Solihull Mental Health NHS Foundation TrustUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult outpatients with pharmacoresistant epilepsy referred to and accepted by the epilepsy clinic will be eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Ketogenic Diet | Other | – |
Primary outcome
50% responder rate
Time frame: Twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manny Bagary, Dr contact
BSMHFT MKD Service contact
Manny Bagary, Dr study director
Consultant Epileptologist and Neuropsychiatrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Birmingham and Solihull Mental Health NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manny Bagary, Dr (m.bagary@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% responder rate (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.