RecruitingNCT04628429

CGRP Inhibition, Autonomic Function, and Migraine

Autonomic Functions in Migraine Patients as a Function of Migraine Status and CGRP Inhibition

Sponsor

Medical University of Vienna

Enrollment

120 participants

Start Date

Oct 1, 2020

Study Type

OBSERVATIONAL

Conditions

Chronic Migraine Episodic Migraine

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how a class of newer migraine prevention medications — CGRP inhibitors — affect the nervous system's ability to automatically regulate functions like heart rate and blood pressure. Understanding this could help explain why these drugs work and whether they have any effects beyond just preventing migraines. **You may be eligible if...** - You have chronic migraine or episodic migraine (with or without aura) - You have tried at least 3 other preventive migraine medications without success - Your insurance covers the cost of the medication - Healthy volunteers without any chronic disease are also eligible **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had brain surgery, heart surgery, a stroke, or a heart attack - You have uncontrolled high blood pressure - You have a known allergy to anti-CGRP medications - You have a neurological condition that could affect test results - Healthy volunteers with a personal or family history of migraine are not eligible as controls Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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