Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures (FOS)

January 9, 2014 updated by: DeGiorgio, Chris, National Center for Complementary and Integrative Health (NCCIH)

Pilot Randomized Double Blind Crossover Study Of Fish Oil [Eicosapentaenoic Acid (EPA) And Docosahexaenoic Acid (DHA)] For Intractable Partial Seizures

The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify cardiac risk factors in people with epilepsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epilepsy is a common and disabling condition, characterized by recurrent seizures. Sudden unexpected death (SUDEP) is a major cause of mortality in people with epilepsy. SUDEP accounts for up to 20% of all cause mortality, and is most common in younger people, especially in their 20's to 40's year olds. In those with drug resistant epilepsy, SUDEP is five times more common than in well-controlled epilepsy. Likely causes of death include cardiac arrhythmias due to impaired autonomic regulation and reduced heart rate variability. Similarly, patients with recent myocardial infarction and congestive heart failure are at higher risk for sudden death, and manifest markedly reduced heart rate variability. Clinical studies of heart disease indicate that n-3 fatty acids, prevent cardiac arrhythmias, reduce mortality after myocardial infarction, and reduce the risk of sudden cardiac death. The mechanism by which EPA and DHA exert their anti-arrhythmia effect is due to inactivation of high frequency sodium and L-type calcium channels in the heart. In addition, n-3 fatty acids improve HRV in cardiac patients, and this reduction in HRV is postulated to be a marker of the anti-arrhythmic effect of n-3 fatty acids. Preliminary data from our group indicates that n-3 fatty acids improve HRV in people with epilepsy, especially those with low HRV (SDNN < 50). The commonality between n-3 fatty acids and improvement in HRV in patients with heart disease and epilepsy serves as a basis for our hypothesis that n-3 fatty acids may reduce the risk of SUDEP in epilepsy. The purpose of this proposal is to determine if n-3 fatty acids reduce seizures and modify cardiac risk in people with epilepsy who are at risk of SUDEP.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age 18 - 70
  • History of intractable localization related/partial onset seizures and generalized tonic/clonic or tonic seizures defined according to International League Against Epilepsy (ILAE) classification as:
  • A history compatible with localization related partial epilepsy
  • A history of generalized tonic clonic or tonic seizures with loss of consciousness
  • Three or more simple partial, complex partial or tonic-clonic seizures per month
  • An EEG and/or an MRI consistent with a localization related epilepsy
  • Evidence of at least three seizures per month for at least two months prior to the study
  • Exposure to at least one antiepileptic drug at adequate dose

Exclusion Criteria:

  • Significant or progressive medical, cardiac, or other illness
  • Allergy to fish products or fish oil
  • History of a coagulation disorder
  • History of non-epileptic seizures
  • Consumption of Fish Oil at any time 30 days or less prior to enrollment
  • Any change in antiepileptic drugs for 30 days or less prior to enrollment
  • Treatment with Warfarin for 30 days or less prior to enrollment
  • Previous poor compliance with therapy
  • Drug or alcohol abuse
  • Uncountable seizures as a result of seizure clustering, or inadequate supervision if the patient cannot count their own seizures.
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Corn Oil Placebo (n-6 fatty acids)
Drug: Placebo
corn oil (n-6 fatty acids)
Other Names:
  • Corn Oil
Experimental: High Dose Fish Oil
2160 mg of EPA + DHA
Drug: High Dose Fish Oil
n-3 fatty acids, 1060 mg EPA + DHA
Experimental: Low Dose Fish Oil
1060 mg of EPA + DHA
Drug: Low Dose Fish Oil
n-3 fatty acids, 2160 mg EPA + DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure Frequency
Time Frame: Study completion (42 weeks)
Seizure frequency (seizures per day or seizures per month)
Study completion (42 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Christopher M DeGiorgio, MD, David Geffen - UCLA School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT003420-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe