CGRP Inhibition, Autonomic Function, and Migraine

Change from Day 0 Cardiovagal Autonomic Dysfunction (CAD) at 5 months

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

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

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 Composite Autonomic Symptom Scale 31 (COMPASS-31) at 5 months

The Composite Autonomic Symptom Scale 31 is a simplified autonomic symptom scoring scheme that follows a homogeneous pattern of scoring throughout the instrument. It quantifies 6 domains: Orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor functions. The 6 domains sum to a total COMPASS-31 score of 0 to 100. A higher score indicates greater autonomic impairment (worse score).

Change from Days 0 Day Impact Questionnaire (HIQ) at 5 months

The Headache Impact Questionnaire is a six-item questionnaire which provides group-level comparisons, patient-level screening, and is responsive to changes in impact of days with headache. The HIQ items cover a substantial range of headache impact as defined by a much larger pool of items and include content areas found in most widely used tools for measuring headache impact. The 6 items sum to a total HIQ score of 0 to 24. A higher score indicates a greater burden of headache (worse score).

Change from Days 0 Non-Headache Day Impact Questionnaire (Non-HIQ) at 5 months

The Non-Headache Day Impact Questionnaire is a six-item questionnaire which provides group-level comparisons, patient-level screening, and is responsive to changes in days without headache. The 6 items sum to a total non-HIQ score of 0 to 24. A higher score indicates a greater burden on headache-free days (worse score).

Change from Days 0 Migraine Disability Assessment Scale (MIDAS) at 5 months

The Migraine Disability Assessment Scale is a 5-item self-administered questionnaire. It is used to quantify headache-related disability; and, has been shown as highly reliable in population-based samples of migraine headache sufferers. The score is the sum total of days affected by migraine. The 5 items sum to a total MIDAS score of 0 to 155. A higher score indicates greater headache-related disability (worse score).