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

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Omega-3
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Medically intractable epilepsy, Omega-3

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega-3

Arm Description

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

Outcomes

Primary Outcome Measures

Seizure frequency

Secondary Outcome Measures

Depressive mood
BDI-2 questionnaire
Anxiety
HAM-A questionnaire
Quality of Life
SF-36 v2 questionnaire
Adverse events

Full Information

First Posted
September 9, 2016
Last Updated
April 19, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02899741
Brief Title
Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Medically intractable epilepsy, Omega-3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Experimental
Arm Description
One group of this study. Omega-3 will be administered for thee months.
Intervention Type
Drug
Intervention Name(s)
Omega-3
Other Intervention Name(s)
Omega-3, Omacor
Intervention Description
1000mg every day for 90 days
Primary Outcome Measure Information:
Title
Seizure frequency
Time Frame
three months
Secondary Outcome Measure Information:
Title
Depressive mood
Description
BDI-2 questionnaire
Time Frame
three months
Title
Anxiety
Description
HAM-A questionnaire
Time Frame
three months
Title
Quality of Life
Description
SF-36 v2 questionnaire
Time Frame
three months
Title
Adverse events
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kon Chu, MD, PhD
Email
stemcell.snu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Joon Kim, MD
Email
dandy8123@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kon Chu, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kon Chu, Professor
Email
stemcell.snu@gmail.com
First Name & Middle Initial & Last Name & Degree
Tae-Joon Kim, Fellow
Email
dandy8123@gmail.com
First Name & Middle Initial & Last Name & Degree
Kon Chu, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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