Clinical trial NCT03143465: Pharmacologically Triggered Migraine Without Aura and Neuroimaging
Official title: MR-Angiografi (MRA) og MR-Spektroskopi (MRS) Hos Raske forsøgspersoner og Patienter Med migræne Uden Aura Provokeret Med Calcitonin Gen-relateret Peptid (CGRP) og Sildenafil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine With Aura
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: CGRP and sildenafil induced headache and MRI changes
timeFrame: 0- 12h
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center, University Hospital
Study officials:
References:
citation: 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.
citation: 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.