Pharmacologically Triggered Migraine Without Aura and Neuroimaging
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|ClinicalTrials.gov Identifier: NCT03143465|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : February 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine With Aura||Drug: Calcitonin Gene-Related Peptide Drug: Sildenafil Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double Blind|
|Primary Purpose:||Basic Science|
|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|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||May 2019|
Drug: Calcitonin Gene-Related Peptide
|Placebo Comparator: Placebo||
- CGRP and sildenafil induced headache and MRI changes [ Time Frame: 0- 12h ]CGRP and sildenafil induced headache and MRI changes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143465
|Danish Headache Center, University Hospital|