NCT02311023

Brief Summary

This is an open trial of intermittent fasting in a group of patients with refractory seizures. Patients will continue on the diet for 6 months to assess the impact of the diet on seizure frequency.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

December 4, 2014

Last Update Submit

November 3, 2016

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Daily total number of seizures

    up to 6 months

Study Arms (1)

Intermittent fasting

EXPERIMENTAL

Patients consume their normal diet for 5 days in the week. On 2 days they only consume 500 Cals if female and 600 Cals if male.

Other: Intermittent fasting

Interventions

Intermittent fastingOTHER
Intermittent fasting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing at least 2 seizures per month
  • BMI of 25 or over

You may not qualify if:

  • Current/previous eating disorder
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLH , The Epilepsy Society

Chalfont Saint Peters, Buckinghamshire, SL9 0RJ, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Research Associate

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 8, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

GB(1)