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Completed

NCT Number: NCT02468622

Transcriptomic and Biochemical Changes During a Migraine Attack

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emma Katrine Hansen

Copenhagen, Glostrup, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood Samples

Other

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

Primary outcomes

  1. Transcriptomic changes

    Time frame: 2 year

    The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack

  2. Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37)

    Time frame: 2 year

    The investigators will use advanced mass spectrometry to measure CGRP levels

  3. Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 )

    Time frame: 2 years

    The investigators will use advanced mass spectrometry to measure PACAP levels

  4. Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP

    Time frame: 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

  5. Changes in Metabolomics

    Time frame: 3 years

    The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples

  6. Changes in Proteomics

    Time frame: 3 years

    The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2015
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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