Status:
COMPLETED
Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Epilepsy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Detailed 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% o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00871377
Start Date
May 1 2008
End Date
August 1 2011
Last Update
February 7 2014
Active Locations (1)
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1
UCLA General Clinical Research Center
Los Angeles, California, United States, 90095