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

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Epilepsy

Treatments

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

Study type

Interventional

Funder types

NIH

Identifiers

NCT00871377
R21AT003420-01A2

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

24 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Corn Oil Placebo (n-6 fatty acids)
Treatment:
Drug: Placebo
High Dose Fish Oil
Experimental group
Description:
2160 mg of EPA + DHA
Treatment:
Drug: High Dose Fish Oil
Low Dose Fish Oil
Experimental group
Description:
1060 mg of EPA + DHA
Treatment:
Drug: Low Dose Fish Oil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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