Transcriptomic and Biochemical Changes During a Migraine Attack

December 12, 2019 updated by: Katrine Falkenberg, Danish Headache Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Emma Katrine Hansen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

15 patients with migraine without aura and 15 paitients with migraine with aura

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MO patients
Patients with migraine without aura. We will take blood samples during spontaneous migraine attacks
Other: Blood samples
There is no intervention, but we will take blood samples during a spontaneous migraine attack
MA patients
Patients with migraine with aura. We will take blood samples during spontaneous migraine attacks
Other: Blood samples
There is no intervention, but we will take blood samples during a spontaneous migraine attack

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptomic changes
Time Frame: 2 year
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)
Time Frame: 2 year
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 )
Time Frame: 2 years
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
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
2 years
Changes in Metabolomics
Time Frame: 3 years
The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples
3 years
Changes in Proteomics
Time Frame: 3 years
The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Transcriptomics

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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