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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Epilepsy	Drug: Placebo; Drug: High Dose Fish Oil; Drug: Low Dose Fish Oil	Phase 2

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	May 2008
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	August 2011

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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
Experimental: Low Dose Fish Oil; 1060 mg of EPA + DHA	Drug: Low Dose Fish Oil; n-3 fatty acids, 2160 mg EPA + DHA

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Seizure Frequency [ Time Frame: Study completion (42 weeks) ]
   Seizure frequency (seizures per day or seizures per month)

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

CenterWatch Listing 

Publications of Results:

DeGiorgio CM, Miller P, Meymandi S, Chin A, Epps J, Gordon S, Gornbein J, Harper RM. RMSSD, a measure of vagus-mediated heart rate variability, is associated with risk factors for SUDEP: the SUDEP-7 Inventory. Epilepsy Behav. 2010 Sep;19(1):78-81. doi: 10.1016/j.yebeh.2010.06.011. Epub 2010 Jul 27.

Other Publications:

DeGiorgio CM, Miller P, Meymandi S, Gornbein JA. n-3 fatty acids (fish oil) for epilepsy, cardiac risk factors, and risk of SUDEP: clues from a pilot, double-blind, exploratory study. Epilepsy Behav. 2008 Nov;13(4):681-4. doi: 10.1016/j.yebeh.2008.08.001. Epub 2008 Sep 7.

DeGiorgio CM, Miller P. n-3 fatty acids (eicosapentanoic and docosahexanoic acids) in epilepsy and for the prevention of sudden unexpected death in epilepsy. Epilepsy Behav. 2008 Nov;13(4):712-3. doi: 10.1016/j.yebeh.2008.06.017. Epub 2008 Aug 9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Novak JL, Miller PR, Markovic D, Meymandi SK, DeGiorgio CM. Risk Assessment for Sudden Death in Epilepsy: The SUDEP-7 Inventory. Front Neurol. 2015 Dec 9;6:252. doi: 10.3389/fneur.2015.00252. eCollection 2015.

DeGiorgio CM, Miller PR, Harper R, Gornbein J, Schrader L, Soss J, Meymandi S. Fish oil (n-3 fatty acids) in drug resistant epilepsy: a randomised placebo-controlled crossover study. J Neurol Neurosurg Psychiatry. 2015 Jan;86(1):65-70. doi: 10.1136/jnnp-2014-307749. Epub 2014 Sep 8.

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:	R21AT003420-01A2 ( U.S. NIH Grant/Contract )
First Posted:	March 30, 2009
Results First Posted:	January 10, 2014
Last Update Posted:	February 7, 2014
Last Verified:	January 2014

Keywords provided by DeGiorgio, Chris, 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:

Epilepsy; Seizures; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms