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

Danish Headache Center

Status and phase: Enrolling; Phase 4

Conditions: Migraine

Treatments: Drug: Calcitonin Gene-Related Peptide; Drug: Erenumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04592952

H-20047793

Details and patient eligibility

About

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

Full 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)

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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
• ≥ 4 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Single-Arm

Experimental group

Description:

Provocation Phase: Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes. Open-Label Treatment Phase: Erenumab packed in a SureClick® Autoinjector Pen (AI)

Treatment:

Drug: Erenumab

Drug: Calcitonin Gene-Related Peptide