Migraine Without AuraNCT00363532
Functional MRI (fMRI) in CGRP Induced Migraine
A study testing infusion of calcitonin gene related peptide (CGRP) in people with Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- infusion of calcitonin gene related peptide (CGRP)
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Hypertension or hypotension.
- Known heart or lung condition.
- Mental illness or substance abuse.
- Other considerable conditions judged by the including doctor.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center, Neurological Dep. Glostrup hospital
Glostrup Municipality, 2770
About this study
Official title: Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by
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.
- Conditions
- Migraine Without Aura
- Being tested
- infusion of calcitonin gene related peptide (CGRP)
- Keywords
- migraine with out aura
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusion of calcitonin gene related peptide (CGRP)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BOLD response before and after CGRP infusion.
Changes in BOLD response before and after injection of sumatriptan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Investigators
- Messoud Ashina, MD,PH.d, Study chair, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363532
- Sponsor's protocol ID
- KA-20060083
- Status last verified
- Jan 2009
- First submitted
- 11 Aug 2006
- Last updated
- 28 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by
- ClinicalTrials.gov ID
- NCT00363532
- Acronym / sponsor ID
- KA-20060083
- Conditions
- Migraine Without Aura
- Keywords
- migraine with out aura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infusion of calcitonin gene related peptide (CGRP) | Drug | – |
Primary outcome
Changes in BOLD response before and after CGRP infusion.
Changes in BOLD response before and after injection of sumatriptan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Messoud Ashina, MD,PH.d study chair
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infusion of calcitonin gene related peptide (CGRP) in people with Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BOLD response before and after CGRP infusion.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.