To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Adenosine in Healthy Volunteers and Migraine Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Occurrence and change of migraine attack
研究概览
简要总结
Adenosine is a nucleoside that plays a role in both vascular and nociceptive systems, and it has been proposed that adenosine may cause headache in particularly sensitive subjects.
Thus, considerable evidence implied that adenosine plays a role in migraine pathophysiology, it is still unknown if intravenous adenosine infusion provokes migraine attacks in healthy subject or in migraine patients. Furthermore, adenosine's effects on the cerebral hemodynamic remains unknown.
This study aims to clarify a possible coherence between adenosine and headache/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
Adenosine
干预措施: Adenosine (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 adenosine compared with before and after infusion of saline
Occurrence and of migraine according to international criteria
次要结局
- Change of diameter of the artery(Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline)
- Change in cerebral hemodynamic(Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline)
- Occurrence and change of headache(Before (-10 minutes) and after infusion (+12 hours) of adenosine compared with before and after infusion of saline)
研究者
Mohammad Al-Mahdi Al-Karagholi
Principal investigator
Danish Headache Center