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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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