Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Koepp

ORCID ID

Contact details

Clinical Neurology
National Hospital for Neurology/Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
+44 (0)20 7837 3611

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263120045

Study information

Scientific title

Acronym

Study hypothesis

To assess the effect of Omega-3 supplementation on seizure frequency in patients with refractory epilepsy.

Ethics approval

Not provided at time of registration

Study design

Double blind parallel randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Nervous System Diseases: Epilepsy

Intervention

1. Omega-3 fatty acid
2. Olive oil

Intervention type

Drug

Phase

Not Specified

Drug names

Omega-3 fatty acid and olive oil

Primary outcome measures

Seizure frequency and adverse events

Secondary outcome measures

1. Antiepileptic drug (AED) levels
2. Patients' global impression
3. Behaviour and mood probes
4. Hamilton Depression rating scale
5 Plasma and red blood cell (RBC) fatty acid concentrations
6. Magnetic resonance (MR) spectroscopic measurement of phosphomonoester and phosphodiester
6. Changes in total brain volume

Overall trial start date

01/02/2003

Overall trial end date

01/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

52 patients from Epilepsy Department

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2003

Recruitment end date

01/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Neurology
London
WC1N 3BG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Charity

Funder name

University College London Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Society for Epilepsy (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16006194

Publication citations

  1. Results

    Yuen AW, Sander JW, Fluegel D, Patsalos PN, Bell GS, Johnson T, Koepp MJ, Omega-3 fatty acid supplementation in patients with chronic epilepsy: a randomized trial., Epilepsy Behav, 2005, 7, 2, 253-258, doi: 10.1016/j.yebeh.2005.04.014.

Additional files

Editorial Notes