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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-11-30

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.

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omega-3

One group of this study. Omega-3 will be administered for thee months.

Group Type EXPERIMENTAL

Omega-3

Intervention Type DRUG

1000mg every day for 90 days

Interventions

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Omega-3

1000mg every day for 90 days

Intervention Type DRUG

Other Intervention Names

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Omega-3, Omacor

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No