NCT04628429 CGRP Inhibition, Autonomic Function, and Migraine
| NCT ID | NCT04628429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Episodic Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2020-10-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy and lactation * Neurosurgical interventions performed within the last 12 months * Coronary bypass surgery or revascularization procedures performed within the last 12 months * 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
Contact & Investigator
Christian Wöber, Prof. MD
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT04628429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Episodic Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04628429 currently recruiting?
Yes, NCT04628429 is actively recruiting participants. Contact the research team at antun.pavelic@meduniwien.ac.at for enrollment information.
Where is the NCT04628429 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT04628429 clinical trial?
NCT04628429 is sponsored by Medical University of Vienna. The principal investigator is Christian Wöber, Prof. MD at Medical University of Vienna. The trial plans to enroll 120 participants.
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