Registry for Migraine - Clinical Core

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Headache Center
• Treatments: Erenumab

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