CGRP Inhibition, Autonomic Function, and Migraine
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)
| Condition(s) | Episodic Migraine, Chronic Migraine |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 migr |
| Who can participate | Inclusion Criteria: * 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 Criteria: * 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 |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Medical University of Vienna |
| Locations | Vienna, Austria |
| Start date | 2020-10-01 |
| NCT ID | NCT04628429 |
| Official listing | https://clinicaltrials.gov/study/NCT04628429 |