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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Antun R Pavelic, MD
antun.pavelic@meduniwien.ac.at
+43 (0)1 40400 - 31170
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
Episodic Migraine
All patients who have been diagnosed with migraine without aura or migraine with aura according to the diagnostic criteria of the International Classification of Headache Disorders, third edition (ICHD-3) and have been unsuccessfully treated with first-line prophylactic medication
Chronic Migraine
All patients who have been diagnosed with chronic migraine (≥15 headache days per month 8 of which with migrainous features) according to the diagnostic criteria of the International Classification of Headache Disorders, third edition (ICHD-3) and have been unsuccessfully treated with first-line prophylactic medication
Healthy Control
Controls must be healthy (free of any diagnosed chronic disease, acute infection requiring medication, family history or personal history of migraine), chosen to be as similar as possible to migraine patients, in terms of age and sex.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov