NCT04592952

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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)

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Calcitonin Gene-Related Peptide	Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
DRUG	Erenumab	Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)

Timeline

• Start date: 2020-10-08
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2020-10-19
• Last updated: 2022-10-24

Locations

1 site across 1 country: Denmark