To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Occurrence and change of migraine attack
研究概览
简要总结
It is not previously investigated whether, there is a correlation between potassium channels and migraine, so it is unclear whether, this signaling pathway through potassium channels has an impact on migraine pathophysiology.
Maxipost (BMS 204352) is a vasoactive molecule that causes vasodilation via the big calcium dependent potassium (BKCa) channel signaling pathway. Maxipost decreases the blood pressure and maxipost infusion causes headache in healthy volunteers. A possible coherence between maxipost and headache/migraine in healthy volunteers and migraine patients is yet to be investigated.
The present study aims to clarify a possible coherence between maxipost and headache/migraine and it will help to shed light on the importance of potassium channels in migraine. In general, the study will contribute to a greater understanding of migraine pathogenesis and possibly lead to development of specific migraine treatment.
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
- 是
入选标准
- •Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers.
- •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
- •All primary headaches, except migraine without aura for migraine patients, according to international classification of headache
- •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
Maxipost
干预措施: Maxipost (Drug)
Saline
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 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline
Occurrence and of migraine according to international criteria
次要结局
- Change in cerebral hemodynamic(Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline)
- Occurrence and change of headache(Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline)
- Change of diameter of the artery(Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline)
研究者
Mohammad Al-Mahdi Al-Karagholi
MD, PhD student, Principal investigator
Danish Headache Center