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