Transcriptomic and Biochemical Changes During Spontaneous Attacks of Migraine With Aura and Migraine Without Aura
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Transcriptomic changes
研究概览
简要总结
Despite the fact that migraine is a common disorder, the pathogenesis is still not fully elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous migraine-attacks will enhance our understanding and may point to new targets for drug development.
详细描述
Migraine is a common neurological disorder affecting approx. 16 % of the European population. Despite the fact that migraine is a common disorder, the pathogenesis is still not sufficiently known.
Studying transcriptomic and biochemical changes during spontaneous migraine-attacks will greatly enhance our understanding of migraine mechanisms and may point to new targets for drug development.
Two blood samples (one for RNA analysis and one for biochemical analysis) are taken on minimum 15 patient with migraine with aura and 15 patients with migraine without aura when they experience a spontaneous migraine attack. A second sample is taken 2 hours after treatment with subcutaneous sumatriptan. Another two blood samples are taken when the patient has been migraine free for at least 5 days and had no other headache for at least 24 hours. A fourth set of blood samples are collected after a cold pressor test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 patients who meet IHS criteria for migraine with or without aura of both sexes,
- •18-70 years,
- •45-95 kg.
排除标准
- •any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week),
- •serious somatic or psychiatric disease,
- •pregnancy,
- •and intake of daily medication (except oral contraceptives).
结局指标
主要结局
Transcriptomic changes
时间窗: 2 year
The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack
Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37)
时间窗: 2 year
The investigators will use advanced mass spectrometry to measure CGRP levels
Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 )
时间窗: 2 years
The investigators will use advanced mass spectrometry to measure PACAP levels
Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP
时间窗: 2 years
The investigators will use advanced mass spectrometry to measure VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP during a migraine attack
Changes in Metabolomics
时间窗: 3 years
The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples
Changes in Proteomics
时间窗: 3 years
The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples
次要结局
未报告次要终点
研究者
Katrine Falkenberg
Medical doctor
Danish Headache Center