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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DeGiorgio, Chris, National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00871377
First received: March 27, 2009
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Epilepsy
Drug: Placebo
Drug: High Dose Fish Oil
Drug: Low Dose Fish Oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Randomized Double Blind Crossover Study Of Fish Oil [Eicosapentaenoic Acid (EPA) And Docosahexaenoic Acid (DHA)] For Intractable Partial Seizures

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Seizure Frequency [ Time Frame: Study completion (42 weeks) ] [ Designated as safety issue: No ]
    Seizure frequency (seizures per day or seizures per month)


Enrollment: 24
Study Start Date: May 2008
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Corn Oil Placebo (n-6 fatty acids)
Drug: Placebo
corn oil (n-6 fatty acids)
Other Name: 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
Other Name: High Dose Fish Oil
Experimental: Low Dose Fish Oil
1060 mg of EPA + DHA
Drug: Low Dose Fish Oil
n-3 fatty acids, 2160 mg EPA + DHA
Other Name: Low Dose Fish Oil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871377

Locations
United States, California
UCLA General Clinical Research Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Investigators
Principal Investigator: Christopher M DeGiorgio, MD David Geffen - UCLA School of Medicine
  More Information

Publications:
Responsible Party: DeGiorgio, Chris, Assistant Professor, National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00871377     History of Changes
Other Study ID Numbers: R21 AT003420-01A2
Study First Received: March 27, 2009
Results First Received: October 31, 2013
Last Updated: January 9, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
epilepsy
cardiac risk factors
memory
cognition
n-3 fatty acids
fish oil
EPA
DHA
seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014