registry for migraine - clinical core

Conditions: Migraine

Summary: this study aims to investigate the effect of erenumab on efficacy outcomes, tolerability outcomes, and patient-reported outcomes in individuals with migraine. furthermore, the study aims to identify clinical predictors of erenumab response.

migraine is a prevalent neurological disorder and a leading cause of years lived with disability worldwide. as of recent, therapies targeting calcitonin gene-related peptide (e.g. erenumab) have been approved for the preventive treatment of migraine. this study aims to investigate the effect of erenumab on efficacy outcomes, tolerability outcomes, and patient-reported outcomes in individuals with migraine. furthermore, the study aims to identify clinical predictors of erenumab response.

Eligibility criteria:
inclusion criteria: * subject has provided informed consent prior to initiation of any study-specific activities/procedures * age greater than or equal to 18 years upon entry into screening * history of migraine (with or without aura) for greater than or equal to 12 months before screening according to the international headache society (ihs) classification ichd-3 (headache classification committee of the international headache society, 2018) based on medical records and/or patient self report * greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening after baseline period * must have demonstrated greater than or equal to 75% compliance in headache diiary usage during baseline period exclusion criteria: subjects are excluded from the study if any of the following criteria apply: disease related * greater than 50 years of age at migraine onset * history of cluster headache or hemiplegic migraine headache * inability to differentiate between migraine from other headaches * the subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour * history or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion prior/concomitant therapy * previously received erenumab (aimovig®) * received an anti-cgrp monoclonal antibody within 3 months prior to the start of the baseline period prior/concurrent clinical study experience * 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. other exclusions * female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test. * female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product. * female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product. * evidence of current pregnancy or breastfeeding per subject self-report or medical records * subject has known sensitivity to any of the products or components to be administered during dosing * subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge