Functional MRI (fMRI) in CGRP Induced Migraine

NCT ID: NCT00363532

Last Updated: 2009-01-28

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

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-07-31

Brief Summary

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In patients known with migraine without aura a migraine headache or migraine like headache will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then be stimulated with noxious heat via a thermode placed at the forehead. At the same time the Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of interest (ROI) will be thalamic region and medulla oblongata.

Then the patients will be given pain relif in form of injection of sumatriptan and the effect of this will also be registered via measuring the BOLD response at the RIO's previously defined. A 3-Tesla MRI scanner will be used in this trail.

This study will give us key knowledge of the trigeminal pain pathway and the central processing i.e sensitization during a migraine attach.

Detailed Description

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Conditions

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Migraine Without Aura

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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infusion of calcitonin gene related peptide (CGRP)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients know with migraine without aura.
* No less then 1 migraine attach pr month and no more then 6 attaches per month.
* Weight 50-100 kg.
* Women must be using secure birthcontrol.

Exclusion Criteria

* Tension type headache more then 1 day/month.
* All other prim. og sec. headache types then migraine without aura.
* Daily use of medication other then birthcontrol pills.
* Pregnant and lactation women.
* Headache on the trail day or 5 days previous to the trail day.
* Contraindications to MRI-scans.
* Hypertension or hypotension.
* Known heart or lung condition.
* Mental illness or substance abuse.
* Other considerable conditions judged by the including doctor.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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Neurological Dep. University of Copenhagen, Denmark, Glostrup Hospital.

Principal Investigators

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Messoud Ashina, MD,PH.d

Role: STUDY_CHAIR

Danish Headache Center

Locations

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Danish Headache Center, Neurological Dep. Glostrup hospital

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KA-20060083

Identifier Type: -

Identifier Source: org_study_id

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