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
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
-
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.