NCT07159750

Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate clinical differences in patients who received preventive treatment with medication targeting calcitonin gene-related peptide (CGRP) or its receptor: monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) during a 2-year period observation phase.

Detailed description

It is a 2-year, multicenter observational study. Patients who meet reimbursement criteria according to local regulations and willing to participate in the study will be included. Monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) will be started and baseline assessment will be conducted. There will be visits every 6 months to assess effectiveness, side-effects, PROMs, and elegibility to continue with the study drug. The observation of patients will last 2 years.

Conditions

• Migraine
• Episodic Migraine
• Chronic Migraine, Headache

Interventions

Type	Name	Description
DRUG	CGRP antibody or gepant	Patients will start anti-CGRP or its receptor antibody or gepants

Timeline

• Start date: 2024-01-02
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

26 sites across 13 countries: United States, Argentina, Chile, Colombia, Croatia, Germany, Italy, Malaysia, Norway, Poland, Portugal, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study