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Transcriptomic and Biochemical Changes During a Migraine Attack

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02468622
Enrollment
30
Registered
2015-06-11
Start date
2015-08-31
Completion date
2016-06-30
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

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

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.

Interventions

OTHERBlood samples

There is no intervention, but we will take blood samples during a spontaneous migraine attack

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Transcriptomic changes2 yearThe 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)2 yearThe investigators will use advanced mass spectrometry to measure CGRP levels
Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 )2 yearsThe investigators will use advanced mass spectrometry to measure PACAP levels
Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP2 yearsThe 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 Metabolomics3 yearsThe investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples
Changes in Proteomics3 yearsThe investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026