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临床试验/NCT03228355
NCT03228355已完成不适用

The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients

Danish Headache Center1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年5月24日最近更新:
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
16
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 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)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Migraine patients of both sexes.
  • 18-60 years.
  • 50-90 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.

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.

Cerebral hemodynamic

时间窗: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline

Change on Media cerebri arterie.

Migraine attack

时间窗: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

Occurrence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Al-Mahdi Al-Karagholi

MD, PhD student

Danish Headache Center

研究点 (1)

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