Transcriptomic and Biochemical Changes During a Migraine Attack
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02468622 |
Recruitment Status :
Completed
First Posted : June 11, 2015
Last Update Posted : December 16, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Migraine | Other: Blood samples |
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 |
Actual Enrollment : | 30 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Transcriptomic and Biochemical Changes During Spontaneous Attacks of Migraine With Aura and Migraine Without Aura |
Study Start Date : | August 2015 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

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 |
- Transcriptomic changes [ Time Frame: 2 year ]The 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) [ Time Frame: 2 year ]The investigators will use advanced mass spectrometry to measure CGRP levels
- 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
- 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
- Changes in Metabolomics [ Time Frame: 3 years ]The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples
- Changes in Proteomics [ Time Frame: 3 years ]The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468622
Denmark | |
Emma Katrine Hansen | |
Copenhagen, Glostrup, Denmark, 2600 |
Principal Investigator: | Emma Katrine Hansen, Doctor | Danish Headache Center |
Responsible Party: | Katrine Falkenberg, Medical doctor, Danish Headache Center |
ClinicalTrials.gov Identifier: | NCT02468622 |
Other Study ID Numbers: |
Transcriptomics |
First Posted: | June 11, 2015 Key Record Dates |
Last Update Posted: | December 16, 2019 |
Last Verified: | December 2019 |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |