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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Corn Oil Placebo (n-6 fatty acids)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

corn oil (n-6 fatty acids)

High Dose Fish Oil

2160 mg of EPA + DHA

Group Type EXPERIMENTAL

High Dose Fish Oil

Intervention Type DRUG

n-3 fatty acids, 1060 mg EPA + DHA

Low Dose Fish Oil

1060 mg of EPA + DHA

Group Type EXPERIMENTAL

Low Dose Fish Oil

Intervention Type DRUG

n-3 fatty acids, 2160 mg EPA + DHA

Interventions

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Placebo

corn oil (n-6 fatty acids)

Intervention Type DRUG

High Dose Fish Oil

n-3 fatty acids, 1060 mg EPA + DHA

Intervention Type DRUG

Low Dose Fish Oil

n-3 fatty acids, 2160 mg EPA + DHA

Intervention Type DRUG

Other Intervention Names

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Corn Oil

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No