Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT00299533
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2006-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polyunsaturated Fatty Acids for Adjunctive Treatment of Refractory Epilepsy
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Prospective Study Evaluating the Usefulness of Polyunsaturated Fatty Acids (PUFA) in Patients Wtih Uncontrolled Epilepsy
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: