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CompletedNCT00363532Updated Jan 28, 2009

Functional MRI (fMRI) in CGRP Induced Migraine

An interventional study of infusion of calcitonin gene related peptide (CGRP) in Migraine Without Aura, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2009-01-28.

Sponsored by Danish Headache Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Migraine Without Aura

Keywords

  • migraine with out aura
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's planned enrollment of 12 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single
Enrollment
12 participants (estimated)

Interventions

  • Druginfusion of calcitonin gene related peptide (CGRP)
06

What researchers measure

Primary outcomes

  1. Changes in BOLD response before and after CGRP infusion.

  2. Changes in BOLD response before and after injection of sumatriptan.

07

Study locations

1 site
  • Danish Headache Center, Neurological Dep. Glostrup hospital
    Glostrup, 2770, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00363532
Lead sponsor
Danish Headache Center
First posted
Aug 15, 2006
Start date
Sep 2006
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Jan 28, 2009

Study contacts

Messoud Ashina, MD,PH.d
study chair · Danish Headache Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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