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

NCT02899741 | Unknown Phase 2

• 1 other identifier: 1508174702
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Medically intractable epilepsy, Omega-3

Outcome Measures

Primary Outcomes (1)

• Seizure frequency

  three months

Secondary Outcomes (4)

• Depressive mood

  three months

• Anxiety

  three months

• Quality of Life

  three months

• Adverse events

  three months

Study Arms (1)

Omega-3

EXPERIMENTAL

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

Drug: Omega-3

Interventions

Omega-3 DRUG

1000mg every day for 90 days

Also known as: Omega-3, Omacor

Omega-3

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Docosahexaenoic Acids; Omacor

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Kon Chu, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kon Chu, MD, PhD

CONTACT

stemcell.snu@gmail.com

Tae-Joon Kim, MD

CONTACT

dandy8123@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)