MR-Angiografi (MRA) og MR-Spektroskopi (MRS) Hos Raske forsøgspersoner og Patienter Med migræne Uden Aura Provokeret Med Calcitonin Gen-relateret Peptid (CGRP) og Sildenafil
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- CGRP and sildenafil induced headache and MRI changes
研究概览
简要总结
Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks.
The investigators will use calcitonin gene-related peptide (CGRP) and sildenafil as pharmacological triggers of migraine, combined with advanced neuroimaging techniques, to investigate the attack initiating pathophysiology.
Both substances have previously been administered to healthy participants and migraine without aura patients, inducing headache and migraine-like-attacks.
The investigators hope to contribute with novelty to the current understanding of the migraine pathophysiology and development of more efficient treatment of migraine.
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)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 50 years
- •Weight: 50-100 kg
- •Diagnosis of migraine without aura (patient group only)
- •Attacks of migraine without aura at least once every second month (patient group only)
排除标准
- •Inconsistent laterality of headache
- •History or family history of migraine (healthy subject group only)
- •Tension-type headache more than one day per month on average (healthy subject group only)
- •Tension-type headache to such a degree that the episodic migraine diagnosis is no longer fulfilled
- •Any other primary headache disorder
- •Daily intake of medication (apart from oral contraceptives)
- •Intake of any medication less than 4 half-lives before study start
- •Daily smoking
- •Pregnant or breastfeeding women
- •Headache 48 h prior to study day
- •Hypertension on the study day (systolic BP>150 mmHg or diastolic BP> 100 mmHg)
- •Hypotension on the study day (systolic BP<90 mmHg or diastolic BP<50 mmHg)
- •History of any cardiovascular disease including cerebrovascular disease
- •Any disorder, that is deemed ineligible for participation by the study physicians
- •Contraindications of MRI
- •No use of safe contraception (women of fertile age only)
研究组 & 干预措施
CGRP
干预措施: Calcitonin Gene-Related Peptide (Drug)
Sildenafil
干预措施: Sildenafil (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
CGRP and sildenafil induced headache and MRI changes
时间窗: 0- 12h
CGRP and sildenafil induced headache and MRI changes
次要结局
未报告次要终点
研究者
Samaira Younis
MD
Danish Headache Center