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

Completed · Phase 2 · Has a placebo group

Conditions studied: Epilepsy

In brief

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

Key facts

Study ID

NCT00871377

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

24

Starts

2008-05-01

Expected to finish

2011-08-01

Last updated by the study team

2014-02-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA General Clinical Research Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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