Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Polyunsaturated Fatty Acids for Adjunctive Treatment of Refractory Epilepsy

This study has been completed.
Sponsor:
Collaborator:
CURE Foundation
Information provided by (Responsible Party):
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00299533
First received: March 3, 2006
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Fish oil (Super Omega-3, 4 caps/d) vs. placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Prospective Study Evaluating the Usefulness of Polyunsaturated Fatty Acids (PUFA) in Patients Wtih Uncontrolled Epilepsy

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • % of subjects with 50% decrease in seizure frequency

Secondary Outcome Measures:
  • % seizure reduction

Estimated Enrollment: 40
Study Start Date: February 2004
Study Completion Date: September 2006
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 and effectively as a treatment for epilepsy.

Background: Patients with intractable epilepsy are often on more than one medication and experience intolerable side effects. Fatty acids have been shown to be protective against seizures in animal models, but there is little human data. Recently, however, a small case series of patients with intractable epilepsy provided evidence of an anti-seizure effect without major side effects. There are no controlled trials of PUFA in humans.

Design/Methods: Patients with uncontrolled partial or generalized epilepsy characterized by at least 4 seizures/month will be randomized to placebo vs. PUFA in a double-blind fashion. Subjects will remain on their current drug(s) while a 4-week baseline seizure count occurs. Dosage will then be titrated over 1 week to 1.1 grams twice daily, and will be followed by a 15-week treatment phase with monthly visits, seizure counts, pill counts, AED levels, adverse event reporting, and neurological examinations. Quality of life will be measured before and after the study using the SF-36 and the QOLIE (Quality of Life in Epilepsy) -31. If subjects wish to continue treatment, they will be given the opportunity at the end of the 20-week period, and those randomized to placebo will have the opportunity to begin treatment with PUFA.

Analysis: The number of subjects achieving a 50% reduction in seizure frequency during the 15-week treatment period relative to the 4-week prospective baseline will be compared for treated vs. control groups using Fisher's exact test. Secondary endpoints will include percent seizure reduction, which will be analyzed using the Mann-Whitney test, and quality of life data, as measured by the SF-36 and QOLIE 31.

Conclusion: There is sufficient preliminary data to suggest that PUFA can be an effective and well-tolerated treatment for epilepsy. If efficacy, safety, and tolerability of PUFA are confirmed, the proposed study will provide the foundation for a larger multi-center trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299533

Sponsors and Collaborators
Brigham and Women's Hospital
CURE Foundation
Investigators
Principal Investigator: Edward B Bromfield, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00299533     History of Changes
Other Study ID Numbers: 2003-P-000025/14
Study First Received: March 3, 2006
Last Updated: August 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014