NCT04628429Recruiting
CGRP Inhibition, Autonomic Function, and Migraine
Autonomic Functions in Migraine Patients as a Function of Migraine Status and CGRP Inhibition
Source: ClinicalTrials.gov · Last updated 10 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 5 Nov 2020
- Start date
- 1 Oct 2020
- Primary completion date
- Dec 2025
- Lead sponsor
- Medical University of Vienna
- Diseases
- Migraine
- NCT number
- NCT04628429
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Oct 2020 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Coronary bypass surgery or revascularization procedures performed within the last 12 months
Other illness
- 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
Other
- Pregnancy and lactation
- Neurosurgical interventions performed within the last 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.