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Transcriptomic and Biochemical Changes During a Migraine Attack

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ClinicalTrials.gov Identifier: NCT02468622
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Katrine Falkenberg, Danish Headache Center

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.

Condition or disease Intervention/treatment
Migraine Other: Blood samples

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Bloodsamples


Information from the National Library of Medicine

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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
Study Population
15 patients with migraine without aura and 15 paitients with migraine with aura
Criteria

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).

Information from the National Library of Medicine

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


Locations
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Denmark
Emma Katrine Hansen
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Emma Katrine Hansen, Doctor Danish Headache Center

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Responsible Party: Katrine Falkenberg, Medical doctor, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02468622     History of Changes
Other Study ID Numbers: Transcriptomics
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases