Transcriptomic and Biochemical Changes During a Migraine Attack

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transcriptomic and Biochemical Changes During Spontaneous Attacks of Migraine With Aura and Migraine Without Aura

Conditions
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Migraine

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine patients who meet IHS criteria for migraine with or without aura of both sexes, 18-70 years, 45-95 kg. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MO patients<br>Patients with migraine without aura. We will take blood samples during spontaneous migraine attacks | Other: Blood samples<br>* There is no intervention, but we will take blood samples during a spontaneous migraine attack<br>|
| MA patients<br>Patients with migraine with aura. We will take blood samples during spontaneous migraine attacks | Other: Blood samples<br>* There is no intervention, but we will take blood samples during a spontaneous migraine attack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptomic changes | The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack | 2 year | 
| Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37) | The investigators will use advanced mass spectrometry to measure CGRP levels | 2 year | 
| Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 ) | The investigators will use advanced mass spectrometry to measure PACAP levels | 2 years | 
| Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP | The investigators will use advanced mass spectrometry to measure VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP during a migraine attack | 2 years | 
| Changes in Metabolomics | The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples | 3 years | 
| Changes in Proteomics | The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples | 3 years |