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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seizure Frequency
Timeframe: Study completion (42 weeks)
Trial details
NCT IDNCT00871377
SponsorNational Center for Complementary and Integrative Health (NCCIH)