Recruiting

CGRP Inhibition, Autonomic Function, and Migraine

ClinicalTrials.gov IDNCT04628429

PhaseNot Applicable

Enrollment120

SponsorMedical University of Vienna

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Episodic Migraine, Chronic Migraine

About this study

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.

Interventions

Drug: Erenumab — anti-CGRP-receptor monoclonal anti-body
Drug: Galcanezumab — anti-CGRP-ligand monoclonal anti-body
Drug: Fremanezumab — anti-CGRP-ligand monoclonal anti-body

Primary outcomes

Change from Day 0 Cardiovagal Autonomic Dysfunction (CAD) at 5 months (Day 0, Month 5 (EOS))
Change from Days 1-31 Cardiovagal Autonomic Dysfunction (CAD) at 5 months (Days 1-31, Month 5 (EOS))
Change from Days 0 Cardiovagal Autonomic Dysfunction (CAD) at Days 1-31 (Day 0, Days 1-31)

Eligibility information

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 migraine) that may affect the results of autonomic tests * Healthy controls must have no personal or family history of migraine

Study locations

Medical University of Vienna, Vienna, 1090 Austria

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.