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

Phase 2

• Conditions: Epilepsy
• Interventions: Drug: Omega-3

• Registration Number: NCT02899741
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-14
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-20
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Seizure frequency	three months

Secondary Outcome Measures

Name	Time	Method
Adverse events	three months
Depressive mood	three months	BDI-2 questionnaire
Anxiety	three months	HAM-A questionnaire
Quality of Life	three months	SF-36 v2 questionnaire

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of