Polyunsaturated Fatty Acids for Adjunctive Treatment of Refractory Epilepsy

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: CURE Foundation

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.