NCT04744129招募中不适用
NN414's Effect in Cerebral Hemodynamics and Headache Induction in Migraine Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Occurrence and change of migraine attack
研究概览
简要总结
To investigate the role of KATP channels on the cerebral hemodynamic in migraine 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)
盲法说明
Quadruple
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 patients of both sexes.
- •18-60 years.
- •50-100 kg.
- •Women of childbearing potential must use adequate contraception.
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.
- •Diabetes mellitus and other endocrinologic disease
研究组 & 干预措施
NN414
Active Comparator
To investigate the role of NN414 compared with placebo in migraine patients.
干预措施: NN414 (Drug)
Saline
Placebo Comparator
To investigate the role of NN414 compared with placebo in migraine patients.
干预措施: Saline (Drug)
结局指标
主要结局
Occurrence and change of migraine attack
时间窗: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Occurrence of migraine according to international criteria
次要结局
- Occurrence and change of headache(Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline)
- Change in cerebral hemodynamic(Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline)
- Change of diameter of the artery(Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline)
研究者
Lili Kokoti
MD, PhD student, Principal investigator
Danish Headache Center
研究点 (1)
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