Epilepsy
Conditions
Keywords
Medically intractable epilepsy, Omega-3
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.
Interventions
DRUGOmega-3
1000mg every day for 90 days
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency | three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive mood | three months | BDI-2 questionnaire |
| Anxiety | three months | HAM-A questionnaire |
| Quality of Life | three months | SF-36 v2 questionnaire |
| Adverse events | three months | — |
Countries
South Korea
Contacts
Primary ContactKon Chu, MD, PhD
Backup ContactTae-Joon Kim, MD
Outcome results
None listed