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

Epilepsy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02899741
• Other study ID #: 1508174702
• Status: Recruiting
• Phase: Phase 2
• First received: September 9, 2016
• Last updated: April 19, 2018
• Start date: August 2016
• Est. completion date: November 2018

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: Kon Chu, MD, PhD
• Email: stemcell.snu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Drug:
• Omega-3
1000mg every day for 90 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency		three months
Secondary	Depressive mood	BDI-2 questionnaire	three months
Secondary	Anxiety	HAM-A questionnaire	three months
Secondary	Quality of Life	SF-36 v2 questionnaire	three months
Secondary	Adverse events		three months