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Functional MRI (fMRI) in CGRP Induced Migraine

Primary Purpose

Migraine Without Aura

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
infusion of calcitonin gene related peptide (CGRP)
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Without Aura focused on measuring migraine with out aura

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danish Headache Center, Neurological Dep. Glostrup hospital

Outcomes

Primary Outcome Measures

Changes in BOLD response before and after CGRP infusion.
Changes in BOLD response before and after injection of sumatriptan.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2006
Last Updated
January 27, 2009
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT00363532
Brief Title
Functional MRI (fMRI) in CGRP Induced Migraine
Official Title
Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Danish Headache Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura
Keywords
migraine with out aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
infusion of calcitonin gene related peptide (CGRP)
Primary Outcome Measure Information:
Title
Changes in BOLD response before and after CGRP infusion.
Title
Changes in BOLD response before and after injection of sumatriptan.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD,PH.d
Organizational Affiliation
Danish Headache Center
Official's Role
Study Chair
Facility Information:
Facility Name
Danish Headache Center, Neurological Dep. Glostrup hospital
City
Glostrup
ZIP/Postal Code
2770
Country
Denmark

12. IPD Sharing Statement

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Functional MRI (fMRI) in CGRP Induced Migraine

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