CGRP Inhibition, Autonomic Function, and Migraine
Autonomic Functions in Migraine Patients as a Function of Migraine Status and CGRP Inhibition
Medical University of Vienna
120 participants
Oct 1, 2020
OBSERVATIONAL
Conditions
Summary
The purpose of this clinical study is to better understand the function of the autonomic nervous system in patients with migraine. We aim to understand whether the autonomic functions change depending on the migraine status (i.e. whether they are between or during attacks) and whether the CGRP monoclonal antibody (mAb) class of drugs affects the autonomic functions. The aim is not to investigate the effect of CGRP-mAb on migraine frequency. Calcitonin gene-related peptide (CGRP) is a neurotransmitter in the nervous system that plays an essential role in the development of migraine headache. Monoclonal antibodies can block the function of this messenger substance. Several studies have shown that this blockade leads to a reduction in the frequency of migraine. In addition to its role in migraine, CGRP also acts on the blood vessels and the autonomic nervous system. The autonomic nervous system is responsible for everything we have no control over in our body. This includes everything from heart rate and blood pressure to our digestion.
Eligibility
Inclusion Criteria5
- Chronic migraine according to ICHD-3
- Episodic migraine without aura or with aura according to ICHD-3
- Unsuccessful treatment with 3 or more established prophylactic drugs
- Medicine costs are covered by health insurance
- Healthy controls must be free from any diagnosed chronic disease or acute infection requiring medication
Exclusion Criteria7
- Pregnancy and lactation
- Neurosurgical interventions performed within the last 12 months
- Coronary bypass surgery or revascularization procedures performed within the last 12 months
- History of transient ischemic attacks (TIA), stroke, stable or unstable angina pectoris, myocardial infarction or uncontrolled hypertension
- Known hypersensitivity to therapy with an anti-CGRP Antibodies
- History of a disorder (other than migraine) that may affect the results of autonomic tests
- Healthy controls must have no personal or family history of migraine
Interventions
anti-CGRP-receptor monoclonal anti-body
anti-CGRP-ligand monoclonal anti-body
anti-CGRP-ligand monoclonal anti-body
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04628429