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

Phase 2

Completed

Conditions: Epilepsy

Interventions: Drug: High Dose Fish Oil
Drug: Low Dose Fish Oil
Drug: Placebo

Registration Number: NCT00871377

Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Dose Fish Oil	High Dose Fish Oil	2160 mg of EPA + DHA
Low Dose Fish Oil	Low Dose Fish Oil	1060 mg of EPA + DHA
Placebo	Placebo	Corn Oil Placebo (n-6 fatty acids)

Primary Outcome Measures