Understanding how CGRP affects autonomic function in migraine patients
Autonomic Functions in Migraine Patients as a Function of Migraine Status and CGRP Inhibition
This study is trying to see how a migraine treatment affects the nervous system in people with migraines, both during attacks and when they're feeling fine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | Erenumab, Galcanezumab, Fremanezumab, Eptinezumab |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04628429 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of the autonomic nervous system in patients suffering from episodic and chronic migraines. It will assess whether autonomic functions vary based on migraine status, such as during an attack or in between attacks, and how these functions may be influenced by CGRP monoclonal antibodies. The study will utilize standardized autonomic tests and scales to evaluate symptoms and gather data on the impact of CGRP inhibition on autonomic function. The findings could provide insights into the relationship between migraines and autonomic symptoms.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic or episodic migraines who have not responded to multiple prophylactic treatments.
Not a fit: Patients with a history of certain cardiovascular conditions or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of migraine mechanisms and lead to improved treatment strategies for patients.
How similar studies have performed: While there have been studies on CGRP's role in migraines, this specific focus on autonomic function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Christian Wöber, Prof. MD — Medical University of Vienna
- Study coordinator: Antun R Pavelic, MD
- Email: antun.pavelic@meduniwien.ac.at
- Phone: +43 (0)1 40400 - 31170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.