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

Recruiting

• Conditions: Migraine; Episodic Migraine; Chronic Migraine, Headache
• Interventions: Drug: CGRP antibody or gepant

• Registration Number: NCT07159750
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Study Timeline

• Study Start: 2024-01-02
• Status Verified: 2025-08
• Study First Submitted: 2025-08-23
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Migraine diagnosis according to ICHD-III.
• Prescription of erenumab, galcanezumab, fremanezumab, eptinezumab, atogepant or rimegepant according to prescriptor criteria and reimbursement criteria according to local regulations.
• Signature of informed consent.

Exclusion Criteria

• Presence of headache different from migraine.
• Active severe psychiatric condition or cognitive impairment which may affect the ability to consent patient's participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Migraine Patients	CGRP antibody or gepant	Migraine patients who initiate a CGRP-targeted treatment

Primary Outcome Measures

Name	Time	Method
Change in Monthly Headache Days and Monthly Migraine Days	Through study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method
HIT-6	Through study completion, an average of 2 years	Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact.
MIDAS	Through study completion, an average of 2 years	Change in MIDAS (Migraine Disability Assessment Scale) scale, to assess disability attributed to migraine.
PGIC	Through study completion, an average of 2 years.	PGIC (Patien Global Impression of Change) scale will be used to assess impression of change in migraine patients.
BAI	Through study completion, an average of 2 years.	Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients.
BDI-II	Through study completion, an average of 2 years.	Change in BDI-II (Beck's Depression Inventory, 2nd version) scale, to assess depression in migraine patients.
MSQ Version 2.1	Through study completion, an average of 2 years.	Changes in MSQ (Migraine-Specific Quality-of-Life) Version 2.1 scale, to assess patient's quality of life.
WPAI	Through study completion, an average of 2 years.	Changes in WPAI (Work Productivity and Activity Impairment) questionnaire, to assess how migraine impacts in work and productivity in migraine patients.
ISI	Through study completion, an average of 2 years.	Changes in ISI (Insomnia Severity Index) scale to assess insomnia in migraine patients.
ASC-12	Through study completion, an average of 2 years.	Changes in ASC-12 (Allodynia Symptom Checklist) scale, to assess allodynia in migraine patients.
m-TOQ	Through study completion, an average of 2 years.	m-TOQ (Migraine Treatment Optimization Questionnaire) scale will be used to assess the effectiveness of migraine treatment.

Trial Locations

Locations (26)

University of Miami, Miller School of Medicine; 🇺🇸 Miami, Florida, United States

FLENI; 🇦🇷 Buenos Aires, Argentina

Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, Chile

Neuromedica; 🇨🇴 Medellín, Colombia

Special Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-Rovigno; 🇭🇷 Rovinj, Croatia

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

LMU University Hospital; 🇩🇪 München, Germany

University of L'Aquila; 🇮🇹 L’Aquila, Italy

University of Modena and Reggio Emilia; 🇮🇹 Modena, Italy

National Neurological Institute C. Mondino Foundation; 🇮🇹 Pavia, Italy

Scroll for more (16 remaining)