NCT02899741Unknown2 期
Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Seizure frequency
研究概览
简要总结
The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Omega-3
Experimental
One group of this study. Omega-3 will be administered for thee months.
干预措施: Omega-3 (Drug)
结局指标
主要结局
Seizure frequency
时间窗: three months
次要结局
- Adverse events(three months)
- Depressive mood(three months)
- Anxiety(three months)
- Quality of Life(three months)
研究者
Kon Chu
Professor
Seoul National University Hospital
研究点 (1)
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