Autonomic Functions in Migraine Patients as a Function of Migraine Status and CGRP Inhibition (CGRP-1)

NCT04628429 RECRUITING

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.

Details

Lead sponsor	Medical University of Vienna
Status	RECRUITING
Enrolment	120
Start date	2020-10-01
Completion	2026-12

Conditions

• Episodic Migraine
• Chronic Migraine

Interventions

• Erenumab
• Galcanezumab
• Fremanezumab

Primary outcomes

• Change from Day 0 Cardiovagal Autonomic Dysfunction (CAD) at 5 months — Day 0, Month 5 (EOS)
  It is derived from the Composite Autonomic severity scale (CASS), an "unbiased and full quantification" of the autonomic functions in the cardiovagal, adrenergic and sudomotor domain. The total CASS score has "a direct clinical meaning since it ranks the generalized dysautonomia as mild, moderate and severe". By isolating two of the indices of the CASS - adrenergic index (AI) and cardiovagal index (CI) - one can quantify the Cardiovascular Autonomic Dysfunction (CAD). Results are referred to as normal (CAD total score = 0) or abnormal. Abnormal values are considered 1-7, indicating presence of CAD.
• Change from Days 1-31 Cardiovagal Autonomic Dysfunction (CAD) at 5 months — Days 1-31, Month 5 (EOS)
  It is derived from the Composite Autonomic severity scale (CASS), an "unbiased and full quantification" of the autonomic functions in the cardiovagal, adrenergic and sudomotor domain. The total CASS score has "a direct clinical meaning since it ranks the generalized dysautonomia as mild, moderate and severe". By isolating two of the indices of the CASS - adrenergic index (AI) and cardiovagal index (CI) - one can quantify the Cardiovascular Autonomic Dysfunction (CAD). Results are referred to as normal (CAD total score = 0) or abnormal. Abnormal values are considered 1-7, indicating presence of CAD.
• Change from Days 0 Cardiovagal Autonomic Dysfunction (CAD) at Days 1-31 — Day 0, Days 1-31
  It is derived from the Composite Autonomic severity scale (CASS), an "unbiased and full quantification" of the autonomic functions in the cardiovagal, adrenergic and sudomotor domain. The total CASS score has "a direct clinical meaning since it ranks the generalized dysautonomia as mild, moderate and severe". By isolating two of the indices of the CASS - adrenergic index (AI) and cardiovagal index (CI) - one can quantify the Cardiovascular Autonomic Dysfunction (CAD). Results are referred to as normal (CAD total score = 0) or abnormal. Abnormal values are considered 1-7, indicating presence of CAD.

Countries

Austria