Polyunsaturated Fatty Acids for Adjunctive Treatment of Refractory Epilepsy
Recruitment status was Active, not recruiting
|First Received Date ICMJE||March 3, 2006|
|Last Updated Date||March 3, 2006|
|Start Date ICMJE||February 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||% of subjects with 50% decrease in seizure frequency|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||% seizure reduction|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Polyunsaturated Fatty Acids for Adjunctive Treatment of Refractory Epilepsy|
|Official Title ICMJE||A Randomized, Double-Blind, Placebo-Controlled, Prospective Study Evaluating the Usefulness of Polyunsaturated Fatty Acids (PUFA) in Patients Wtih Uncontrolled Epilepsy|
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.
Polyunsaturated Fatty Acids for Treatment of Refractory Epilepsy
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Fish oil (Super Omega-3, 4 caps/d) vs. placebo|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||September 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00299533|
|Other Study ID Numbers ICMJE||2003-P-000025/14|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Brigham and Women's Hospital|
|Collaborators ICMJE||CURE Foundation|
|Information Provided By||Brigham and Women's Hospital|
|Verification Date||March 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP