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
Overview
- Phase
- Not Applicable
- Intervention
- Calcitonin Gene-Related Peptide
- Conditions
- Migraine With Aura
- Sponsor
- Danish Headache Center
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- CGRP and sildenafil induced headache and MRI changes
- Last Updated
- 7 years ago
Overview
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.
Investigators
Samaira Younis
MD
Danish Headache Center
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
Arms & Interventions
CGRP
Intervention: Calcitonin Gene-Related Peptide
Sildenafil
Intervention: Sildenafil
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
CGRP and sildenafil induced headache and MRI changes
Time Frame: 0- 12h
CGRP and sildenafil induced headache and MRI changes