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

April 19, 2018 updated by: Kon Chu, Seoul National University Hospital
The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3
One group of this study. Omega-3 will be administered for thee months.
Drug: Omega-3
1000mg every day for 90 days
Other Names:
  • Omega-3, Omacor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seizure frequency
Time Frame: three months
three months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508174702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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