Intermittent Fasting in Refractory Epilepsy

Epilepsy Clinical Trial

Official title:

A Single Centre Open Six Months Study of Intermittent Fasting for the Treatment of People With Refractory Epilepsy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02311023
• Other study ID #: UCLH 13/0389
• Status: Terminated
• Phase: Phase 2
• First received: December 4, 2014
• Last updated: November 3, 2016
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Description:

A proportion of people with epilepsy continue to have seizures despite all conventional treatment options. The classical ketogenic diet and its variants have been shown to help some of these people. However, these diets require significant medical and dietician supervision,and is frequently not well tolerated. There is a need to develop other diet therapy that is easier to administer and more acceptable to the patient. This trial undertaken in adult overweight UCLH outpatients examines the effect of an intermittent fasting diet on seizures. Subjects may consume their normal diet for 5 days a week. On 2 days in a week, they consume only 25% of their daily calorie requirement. Subjects will continue on the diet for 6 months. Intermittent fasting has been shown in animal studies to activate a number of signalling pathways which are thought to reduce seizure thresholds. Has intermittent fasting in humans might be expected to reduce seizures.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Experiencing at least 2 seizures per month

• .BMI of 25 or over

Exclusion Criteria:

• Current/previous eating disorder

• Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Other:
• Intermittent fasting

Locations

Country	Name	City	State
United Kingdom	UCLH , The Epilepsy Society	Chalfont St Peters	Buckinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily total number of seizures		up to 6 months	No