Migraine With Aura
Conditions
Brief summary
Migraine is a highly disabling disorder affecting 14% of the general population Worldwide and ranked as the 6th most debilitating disease worldwide by the WHO. One of the most fundamental questions of migraine, which remains to be elucidated, is the mechanism behind the generation of migraine attacks. 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.
Interventions
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 50 years * 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
* Inconsistent laterality of headache * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGRP and sildenafil induced headache and MRI changes | 0- 12h | CGRP and sildenafil induced headache and MRI changes |
Countries
Denmark
Outcome results
None listed