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
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52 weeks
Total Duration
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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
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
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
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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.
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