Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.

Detailed Description
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This study will enroll total 30 patients with medically intractable epilepsy. The patients will be fully assessed on the enrollment, and then seizure frequency will be counted for three months without changing medication. After three months, Omega-3 will be administered for next three months. Seizure frequency, questionnaires evaluating mood and QOL, and adverse events are evaluated at each visit.

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Omega-3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with medically intractable, focal or generalized, epilepsy: Patients with localization-related partial onset or generalized tonic/clonic seizure according to the International League Against Epilepsy (ILAE) can be included. Medically intractable epilepsy means that recurrent seizures occur even though two or more anti-epileptic drugs have been used appropriately for over one year. Seizure frequency criteria: three seizures per one month for recent 3 months before enrollment Seizure criteria: simple partial, complex partial, or tonic-clonic seizures Subjects with normal cognitive function: patients who can perform normal daily life. If not definite, enrollment will be done with K-MMSE score over 27. Exclusion Criteria: Poor general medical condition: comorbid with heart, lung, liver diseases Patients who have history of pseudo-seizure Anti-epileptic drugs has been changed in recent one month. Chronic alcoholic Seizure count cannot be done since seizures occur successively. Allergy to fish High risk of bleeding such as trauma or operation Liver function abnormality Pregnant or lactating women, or women who plans to have children Patients who have participated in the other clinical trial in recent one month

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3<br>One group of this study. Omega-3 will be administered for thee months. | Drug: Omega-3<br>* 1000mg every day for 90 days<br>* Other names: Omega-3, Omacor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive mood | BDI-2 questionnaire | three months | 
| Anxiety | HAM-A questionnaire | three months | 
| Quality of Life | SF-36 v2 questionnaire | three months | 
| Adverse events |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medically intractable epilepsy, Omega-3