Studies nerve function in people with migraine, with and without CGRP-blocking drugs
Observes autonomic nerve function in adults with migraine, comparing attacks and symptom-free periods.
Plain-language title generated from the registry record
Registry title: CGRP Inhibition, Autonomic Function, and Migraine
Key facts
- Where
- Vienna, AustriaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT04628429, who can take part
Where in Austria
- Medical University of ViennaVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Vienna
- Trial code
- NCT04628429
- Record updated
- 10 December 2024
- Original description
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.Read full original descriptionShow less
Autonomic Functions in Migraine Patients as a Function of Migraine Status and CGRP Inhibition
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.
Inclusion: 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: 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; Pregnancy and lactation; Neurosurgical interventions performed within the last 12 months.