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

Summary

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

Timeline

Start

2020-10-08

Primary completion

2025-08-01

Completion

2025-08-01

Outcome

Missed primary endpoint

paper Conversely, 13 of 25 (52%) where CGRP infusion did not induce a migraine achieved the same endpoint (p = 0.498). PMID 38859744 ↗

paper no significant differences between the ≥50% reduction in either monthly migraine or monthly headache days of moderate to severe intensity between CGRP-sensitive and PMID 38859744 ↗

Publications

• Al-Khazali HM, Ashina H, Christensen RH, Wiggers A, Rose K, Iljazi A, Amin FM, Ashina M, Snellman J, Maio-Twofoot T, Schytz HW. Hypersensitivity to CGRP as a predictive biomarker of migraine prevention with erenumab. Cephalalgia. 2024 Jun;44(6):3331024241258734. doi: 10.1177/03331024241258734.
• Al-Khazali HM, Ashina H, Christensen RH, Wiggers A, Rose K, Iljazi A, Schytz HW, Amin FM, Ashina M. An exploratory analysis of clinical and sociodemographic factors in CGRP-induced migraine attacks: A REFORM study. Cephalalgia. 2023 Oct;43(10):3331024231206375. doi: 10.1177/03331024231206375.
• Al-Khazali HM, Ashina H, Wiggers A, Rose K, Iljazi A, Christensen RH, Schytz HW, Amin FM, Ashina M. Calcitonin gene-related peptide causes migraine aura. J Headache Pain. 2023 Sep 7;24(1):124. doi: 10.1186/s10194-023-01656-4.
• Karlsson WK, Ashina H, Cullum CK, Christensen RH, Al-Khazali HM, Amin FM, Ashina M; REFORM Investigators. The Registry for Migraine (REFORM) study: methodology, demographics, and baseline clinical characteristics. J Headache Pain. 2023 Jun 12;24(1):70. doi: 10.1186/s10194-023-01604-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Calcitonin Gene-Related Peptide	Peptide	1.5 ug	Intravenous
Subject	Erenumab	Monoclonal antibody	70 mg	—
Subject	Erenumab	Monoclonal antibody	140 mg	—

Indications