Transcriptomic and Biochemical Changes During a Migraine Attack
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedDecember 16, 2019
December 1, 2019
10 months
June 4, 2015
December 12, 2019
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (2)
MO patients
Patients with migraine without aura. We will take blood samples during spontaneous migraine attacks
MA patients
Patients with migraine with aura. We will take blood samples during spontaneous migraine attacks
Interventions
There is no intervention, but we will take blood samples during a spontaneous migraine attack
Eligibility Criteria
15 patients with migraine without aura and 15 paitients with migraine with aura
You may qualify if:
- Migraine patients who meet IHS criteria for migraine with or without aura of both sexes,
- years,
- kg.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emma Katrine Hansen
Copenhagen, Glostrup, 2600, Denmark
Biospecimen
Bloodsamples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emma Katrine Hansen, Doctor
Danish Headache Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
June 4, 2015
First Posted
June 11, 2015
Study Start
August 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
December 16, 2019
Record last verified: 2019-12