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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02899741
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
27
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Nov 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Seizure frequency [three months]

    Secondary Outcome Measures

    1. Depressive mood [three months]

      BDI-2 questionnaire

    2. Anxiety [three months]

      HAM-A questionnaire

    3. Quality of Life [three months]

      SF-36 v2 questionnaire

    4. Adverse events [three months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Kon Chu, MD, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kon Chu, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02899741
    Other Study ID Numbers:
    • 1508174702
    First Posted:
    Sep 14, 2016
    Last Update Posted:
    Apr 20, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Kon Chu, Professor, Seoul National University Hospital
    Medically intractable epilepsy, Omega-3
    Additional relevant MeSH terms:
    Epilepsy

    Study Results

    No Results Posted as of Apr 20, 2018