CGRP Inhibition, Autonomic Function, and Migraine

NCT04628429 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-12-10

No results posted yet for this study

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.

Conditions

  • Episodic Migraine
  • Chronic Migraine

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Christian Wöber, Prof. MD · Medical University of Vienna

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04628429 on ClinicalTrials.gov