NCT02147561已完成4 期
A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Adverse Events
研究概览
简要总结
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ethnically Korean with a diagnosis of chronic migraine
排除标准
- •Anticipated need for botulinum toxin treatment for any reason other than chronic migraine during the study
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
结局指标
主要结局
Percentage of Patients With Adverse Events
时间窗: 28 Days
An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
次要结局
- Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score(Baseline, Day 28)
- Physician Global Assessment of Outcome on a 3-Point Scale(Baseline, Day 28)
研究者
研究点 (1)
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