Pharmacologically Triggered Migraine Without Aura and Neuroimaging
NCT ID: NCT03143465
Last Updated: 2019-02-15
Study Results
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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UNKNOWN
NA
36 participants
INTERVENTIONAL
2016-08-31
2019-05-31
Brief Summary
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The investigators will use calcitonin gene-related peptide (CGRP) and sildenafil as pharmacological triggers of migraine, combined with advanced neuroimaging techniques, to investigate the attack initiating pathophysiology.
Both substances have previously been administered to healthy participants and migraine without aura patients, inducing headache and migraine-like-attacks.
The investigators hope to contribute with novelty to the current understanding of the migraine pathophysiology and development of more efficient treatment of migraine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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CGRP
Calcitonin Gene-Related Peptide
Sildenafil
Sildenafil
Placebo
Placebo
Interventions
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Calcitonin Gene-Related Peptide
Sildenafil
Placebo
Eligibility Criteria
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Inclusion Criteria
* Weight: 50-100 kg
* Diagnosis of migraine without aura (patient group only)
* Attacks of migraine without aura at least once every second month (patient group only)
Exclusion Criteria
* History or family history of migraine (healthy subject group only)
* Tension-type headache more than one day per month on average (healthy subject group only)
* Tension-type headache to such a degree that the episodic migraine diagnosis is no longer fulfilled
* Any other primary headache disorder
* Daily intake of medication (apart from oral contraceptives)
* Intake of any medication less than 4 half-lives before study start
* Daily smoking
* Pregnant or breastfeeding women
* Headache 48 h prior to study day
* Hypertension on the study day (systolic BP\>150 mmHg or diastolic BP\> 100 mmHg)
* Hypotension on the study day (systolic BP\<90 mmHg or diastolic BP\<50 mmHg)
* History of any cardiovascular disease including cerebrovascular disease
* Any disorder, that is deemed ineligible for participation by the study physicians
* Contraindications of MRI
* No use of safe contraception (women of fertile age only)
18 Years
50 Years
ALL
Yes
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Samaira Younis
MD
Locations
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Danish Headache Center, University Hospital
Glostrup Municipality, , Denmark
Countries
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References
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Younis S, Christensen CE, Toft NM, Soborg T, Amin FM, Hougaard A, Ashina M. Investigation of distinct molecular pathways in migraine induction using calcitonin gene-related peptide and sildenafil. Cephalalgia. 2019 Dec;39(14):1776-1788. doi: 10.1177/0333102419882474. Epub 2019 Nov 4.
Christensen CE, Younis S, Lindberg U, Boer VO, de Koning P, Petersen ET, Paulson OB, Larsson HBW, Amin FM, Ashina M. Ultra-high field MR angiography in human migraine models: a 3.0 T/7.0 T comparison study. J Headache Pain. 2019 May 6;20(1):48. doi: 10.1186/s10194-019-0996-x.
Other Identifiers
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H-15019063
Identifier Type: -
Identifier Source: org_study_id
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