Actively Recruiting

Age: 18Years - 64Years
All Genders
Healthy Volunteers
ID04628429

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

Led by Medical University of Vienna · Updated on 2024-12-10

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the autonomic nervous system functions in people with migraine and how it may change depending on whether they are between or during migraine attacks. The study also explores whether drugs called CGRP monoclonal antibodies, which block a messenger substance involved in migraine development, affect autonomic nervous system functions. Migraines are common and disabling, and while CGRP antibodies have been shown to reduce migraine frequency, their impact on autonomic functions is not well understood. The study involves patients with episodic or chronic migraine who have not responded to standard preventive medications, as well as healthy control participants without migraine or chronic disease. Patients will be observed over five months, including baseline visits and an evaluation visit, during which autonomic function scores will be measured and compared before and during treatment with anti-CGRP monoclonal antibodies such as Erenumab, Galcanezumab, or Fremanezumab. Controls will have one testing visit and a follow-up call. Participants will undergo standardized autonomic function tests measuring cardiovagal autonomic dysfunction and complete questionnaires assessing migraine impact, autonomic symptoms, quality of life, and psychiatric symptoms. These evaluations will occur at baseline, during migraine attack phases, and after five months of treatment or observation. Researchers will monitor changes in autonomic function scores and migraine-related questionnaires to understand the effects of migraine status and CGRP inhibition over time.

CONDITIONS

Brief Title

CGRP Inhibition, Autonomic Function, and Migraine

Who Can Participate

Age: 18Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 64 years
  • Diagnosed with chronic migraine according to ICHD-3
  • Diagnosed with episodic migraine with or without aura according to ICHD-3
  • Unsuccessful treatment with three or more established prophylactic migraine drugs
  • Medicine costs covered by health insurance
  • Healthy controls must be free from any diagnosed chronic disease or acute infection requiring medication
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • Neurosurgical interventions within the last 12 months
  • Coronary bypass surgery or other revascularization procedures within the last 12 months
  • History of transient ischemic attacks, stroke, stable or unstable angina, myocardial infarction, or uncontrolled hypertension
  • Known allergy to anti-CGRP antibody therapy
  • History of disorders other than migraine that may affect autonomic test results
  • Healthy controls must have no personal or family history of migraine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants are evaluated for eligibility based on medical history and inclusion/exclusion criteria.

Baseline Assessments

Duration - Up to 1 month

Participants undergo initial clinical assessments to establish baseline autonomic function and migraine status.

1 to 2 clinical visits including a baseline visit on Day 0 and an additional visit between Days 1 and 30.

Observation Period

Duration - Up to 1 month

Participants with migraine are observed during different migraine phases to assess autonomic function off prophylactic medication, including ictal and peri-ictal phases. Healthy controls undergo one testing visit.

Migraine patients: multiple assessments within Days 1 to 31. Healthy controls: 1 testing visit on Day 0.

Anti-CGRP Treatment Observation

Duration - 5 months

Participants receiving anti-CGRP monoclonal antibodies are observed over 5 months to evaluate changes in autonomic function during treatment.

1 evaluation visit at Month 5 (End of Study) plus telephone follow-up.

Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

A

Antun R Pavelic, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.

GBD 2017 Disease and Injury Incidence and Prevalence Collaborators

https://pubmed.ncbi.nlm.nih.gov/30496104

Increased VIP levels in peripheral blood outside migraine attacks as a potential biomarker of cranial parasympathetic activation in chronic migraine.

Eva Cernuda-Morollón, Pablo Martínez-Camblor, Rocío Alvarez...

https://pubmed.ncbi.nlm.nih.gov/24847167