The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Aura
研究概览
简要总结
In a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.
详细描述
Migraine with aura is associated to an increased risk of stroke. The mechanism behind such increased risk is not fully understood. Cilostazol induce headache and migraine in migraine patients and is used as secondary prevention of stroke. The effect on aura induction is not known. We investigate the aura inducing potential of cilostazol and associated changes in endothelial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine with aura
- •Minimum of 2 attacks/year
排除标准
- •Chronic tension type headache
- •Cardiac arrhythmias
研究组 & 干预措施
Active
Cilostazol 200 mg single dose
干预措施: Cilostazol (Drug)
Placebo
Placebo capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Aura
时间窗: 24 hours
Induction of aura reported by an aura diary for 24 hours post medication
次要结局
- Migraine(24 hours)
- Endothelial response(3 hours)
研究者
Christina Kruuse
Associate professor, consultant neurologist
Herlev Hospital