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

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital

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