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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2025
  • participants needed
    400
  • sponsor
    Danish Headache Center
Updated on 26 January 2021
headache
calcitonin gene-related peptide
erenumab
calcitonin

Summary

To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.

Description

This is a single-center, non-randomized, single-arm, open-label study, in which adults with episodic or chronic migraine will receive intravenous infusion with calcitonin gene-related peptide and subsequently be treated with erenumab. The study will consist of the following

elements
  • Provocation Phase (1 experimental day with intravenous infusion of calcitonin gene-related peptide)
  • Screening/Baseline Phase (4 weeks)
  • Open-Label Treatment Phase (24 weeks)

Details
Condition Migraine, Migraine (Pediatric), Migraine (Adult), Primary Stabbing Headache, Migraine and Cluster Headaches, Migraine (Adult), Migraine and Cluster Headaches, Migraine (Pediatric), migraines
Treatment Calcitonin Gene-Related Peptide, Erenumab
Clinical Study IdentifierNCT04592952
SponsorDanish Headache Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years of age upon entry into screening
History of migraine with or without aura for 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
headache days that meet criteria as migraine days per month on average across the 3 months before screening
Subject has provided informed consent prior to initiation of any study-specific activities/procedures
Must have demonstrated greater than or equal to 75% compliance in Headache Diary usage during the 4-week run-period prior to Day 1 of the open-label treatment phase

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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