Functional MRI (fMRI) in CGRP Induced Migraine

Migraine Without Aura Clinical Trial

Official title:

Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363532
• Other study ID #: KA-20060083
• Status: Completed
• Phase: N/A
• First received: August 11, 2006
• Last updated: January 27, 2009
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: January 2009
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine without Aura

Intervention

Drug:
• infusion of calcitonin gene related peptide (CGRP)

Locations

Country	Name	City	State
Denmark	Danish Headache Center, Neurological Dep. Glostrup hospital	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	Changes in BOLD response before and after CGRP infusion.
Primary	Changes in BOLD response before and after injection of sumatriptan.