Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab

Exclusion Criteria

• •\> 50 years of age at migraine onset
• •History of cluster headache or hemiplegic migraine
• •Inability to differentiate migraine from other headaches
• •The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
• •History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
• •Previously received erenumab (Aimovig)
• •Received anti-CGRP monoclonal antibody within 3 months prior to the CGRP-infusion
• •Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
• •Female subjects of childbearing potential with a positive pregnancy test during any study visit
• •Female subject is pregnant or breastfeeding or planning to become pregnant during the study
• •Evidence of current pregnancy or breastfeeding
• •Female subject of childbearing potential unwilling to use an acceptable method of effective contraception
• •Hypertension on the experimental day defined as systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg
• •Hypotension on the experimental day defined as systolic blood pressure \< 90mmHg or diastolic blood pressure \< 50mmHg
• •Any headache (including migraine) within 24 hours prior to the start of the CGRP-infusion
• •Intake of any analgesics or migraine-specific medications within 24 hours prior to the start of the CGRP-infusion
• •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge