Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Area under the curve of headache intensity
研究概览
简要总结
Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.
The aim of the study is to identify factors that protect against headache by studying headache after provocation in people who never have had a headache (headache resistant) versus non-resistant controls.
The investigators will use isosorbide mononitrate as a pharmacological trigger of headache. The provocation is performed by investigators who are blinded to the grouping of the participants.
The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The investigators are blinded to the case-control grouping of the participants.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
- •Weight: 45 kg to 95 kg
排除标准
- •Daily consumption of any medication.
- •Consumption of any medication less than 12 hours prior to the study day.
- •Headache on the study day or 48 hours prior to the study day.
- •Amnestic or clinical signs of hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg).
- •Any severe cardiovascular disease, including cerebrovascular illness.
- •Amnestic or clinical signs of current mental illness.
- •Amnestic or clinical signs of current substance or drug abuse.
- •Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.
研究组 & 干预措施
Isosorbide mononitrate
Cases and controls both receive one tablet Imdur® 60 mg (isosorbide mononitrate) on the study day.
干预措施: Isosorbide Mononitrate 60 MG (Drug)
结局指标
主要结局
Area under the curve of headache intensity
时间窗: 5 hours
Area under the curve of headache intensity from 0 - 5 hours post tablet administration
次要结局
- Area under the curve of headache intensity(12 hours)
研究者
Isa Amalie Olofsson
Medical Doctor, PhD student
Danish Headache Center