NCT04012047已完成不适用
Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Headache
研究概览
简要总结
To investigate the role of KATP channels in migraine with aura patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine with aura patients of both sexes.
- •18-60 years.
- •50-100 kg.
排除标准
- •Headache less than 48 hours before the tests start
- •Daily consumption of drugs of any kind other than oral contraceptives
- •Pregnant or nursing women.
- •Cardiovascular disease of any kind, including cerebrovascular diseases.
研究组 & 干预措施
Levcromakalim
Active Comparator
干预措施: Levcromakalim (Drug)
Saline
Placebo Comparator
干预措施: Saline (Drug)
结局指标
主要结局
Headache
时间窗: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of headache
Migraine
时间窗: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of migraine
Aura
时间窗: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of aura
次要结局
- Blood pressure(Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline)
- Family history(After including the patients in the study.)
- Heart rate(Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline)
- The area under the curve (AUC) for headache(Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline)
研究者
Mohammad Al-Mahdi Al-Karagholi
MD, PhD student
Danish Headache Center
研究点 (1)
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