Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures (NCT00871377) | Clinical Trial Compass
CompletedPhase 2
Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures
United States24 participantsStarted 2008-05
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Seizure Frequency
Timeframe: Study completion (42 weeks)
Trial details
NCT IDNCT00871377
SponsorNational Center for Complementary and Integrative Health (NCCIH)