Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Headache incidence
研究概览
简要总结
To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine with aura patients of both sexes.
- •18-70 years.
- •50-100 kg.
排除标准
- •Headache less than 48 hours before the tests start
- •Daily consumption of drugs of any kind that investigator deems might affect study results or safety.
- •Pregnant or nursing women.
- •Cardiovascular disease of any kind, including cerebrovascular diseases.
- •Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year
- •Known cluster headache according to International Classification of Headache Disorders version
- •Psychiatric disorder
- •Smoking or abuse of drugs or alcohol
- •Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) on day of inclusion.
- •Hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg) on day of inclusion.
研究组 & 干预措施
Levcromakalim
干预措施: Levcromakalim (Drug)
Saline
干预措施: Saline (Drug)
结局指标
主要结局
Headache incidence
时间窗: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Aura incidence
时间窗: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Migraine incidence
时间窗: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
次要结局
- Heart rate(10 minutes before until 120 minutes after infusion of levcromakalim or placebo)
- Blood pressure(10 minutes before until 120 minutes after infusion of levcromakalim or placebo)
- Headache intensity(10 minutes before until 24 hours after infusion of levcromakalim or placebo)
研究者
Andreas Vinther Thomsen
Principal Investigator
Danish Headache Center