Transcriptomic and Biochemical Changes During a Migraine Attack

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468622
• Other study ID #: Transcriptomics
• Status: Completed
• Start date: August 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Denmark	Emma Katrine Hansen	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptomic changes	The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack	2 year
Primary	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
Primary	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
Primary	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
Primary	Changes in Metabolomics	The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples	3 years
Primary	Changes in Proteomics	The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples	3 years