Actively Recruiting

Age: 18Years - 64Years
All Genders
Healthy Volunteers
NCT04628429

CGRP Inhibition, Autonomic Function, and Migraine

Led by Medical University of Vienna · Updated on 2024-12-10

120

Participants Needed

1

Research Sites

321 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CGRP Inhibition, Autonomic Function, and Migraine

Who Can Participate

Age: 18Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of chronic migraine according to ICHD-3 criteria
  • Diagnosis of episodic migraine with or without aura according to ICHD-3 criteria
  • Unsuccessful treatment with three or more established migraine preventive drugs
  • Medicine costs are covered by health insurance
  • Healthy controls must have no diagnosed chronic disease or acute infection requiring medication
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Neurosurgical interventions within the last 12 months
  • Coronary bypass surgery or other revascularization procedures within the last 12 months
  • History of transient ischemic attacks (TIA), stroke, stable or unstable angina pectoris, myocardial infarction, or uncontrolled hypertension
  • Known allergy to anti-CGRP antibody therapy
  • History of disorders (other than migraine) that may affect autonomic test results
  • Healthy controls must have no personal or family history of migraine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

A

Antun R Pavelic, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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