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Transcriptomic and Biochemical Changes During a Migraine Attack

NCT ID: NCT02468622

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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MO patients

Patients with migraine without aura. We will take blood samples during spontaneous migraine attacks

Blood samples

Intervention Type OTHER

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

Blood samples

Intervention Type OTHER

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

Interventions

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Blood samples

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Katrine Falkenberg

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emma Katrine Hansen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

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Emma Katrine Hansen

Copenhagen, Glostrup, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Transcriptomics

Identifier Type: -

Identifier Source: org_study_id