NCT03425110

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2.9 years

First QC Date

February 1, 2018

Last Update Submit

February 8, 2018

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 50% responder rate

    Twelve months

Interventions

Modified Ketogenic DietOTHER

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult outpatients with pharmacoresistant epilepsy referred to and accepted by the epilepsy clinic will be eligible to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complex Epilepsy Service, The Barberry, BSMHFT

Birmingham, West Midlands, B15 2FG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Manny Bagary, Dr

    Consultant Epileptologist and Neuropsychiatrist

    STUDY DIRECTOR

Central Study Contacts

Manny Bagary, Dr

CONTACT

m.bagary@nhs.net

BSMHFT MKD Service

CONTACT

bsmhft.modifiedketogenicdiet@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 7, 2018

Study Start

July 21, 2015

Primary Completion

June 30, 2018

Study Completion

September 1, 2018

Last Updated

February 9, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)