Status:
COMPLETED
Polyunsaturated Fatty Acids for Adjunctive Treatment of Refractory Epilepsy
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
CURE Foundation
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
We are studying whether the addition of fish oil capsules, containing 2.2 gm of polyunsaturated fatty acids, when added to antiepileptic drugs improve seizure control.
Detailed Description
Polyunsaturated Fatty Acids for Treatment of Refractory Epilepsy ABSTRACT Objective: The primary objective of the study is to determine whether polyunsaturated fatty acids (PUFA) can be used safely ...
Eligibility Criteria
Inclusion
- Eligible subjects must have at least one seizure or seizure cluster per week, or at least four per month. They may have partial or generalized epilepsy as diagnosed by a board certified neurologist with subspecialty training in epilepsy. Subjects must be at least 18 years of age, and able to give signed informed consent.
Exclusion
- Potential subjects will be considered ineligible for the study if they exhibit frequent vomiting, inability to swallow, an allergy to fatty acids, or a medical condition that could interfere with oral medication intake. Subjects with markedly elevated cholesterol levels (\>260) or who receive drugs that affect lipid metabolism, such as HMG CoA inhibitors, will be excluded as well. Due to the theoretical possibility of platelet dysfunction, subjects taking Coumadin® or high doses of aspirin (\>325mg daily) will not be considered eligible for the study. Subjects who are pregnant or nursing will also be excluded due to any possible teratogenic effects on the fetus.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00299533
Start Date
February 1 2004
End Date
September 1 2006
Last Update
August 16 2013
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