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

NCT07159750 | Recruiting FDA Drug

• 1 other identifier: EOM(AG)008/2024(6234)
• Study Type: observational
• Target: 700
• Locations: 13 countries
• Sites: 26

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.

Conditions

Migraine; Episodic Migraine; Chronic Migraine, Headache

Keywords

Migraine; Prevention; Chronic Migraine; Episodic Migraine; galcanezumab; erenumab; fremanezumab; eptinezumab; rimegepant; atogepant

Outcome Measures

Primary Outcomes (1)

• Change in Monthly Headache Days and Monthly Migraine Days

  Through study completion, an average of 2 years

Secondary Outcomes (10)

• HIT-6

  Through study completion, an average of 2 years

• MIDAS

  Through study completion, an average of 2 years

• PGIC

  Through study completion, an average of 2 years.

• BAI

  Through study completion, an average of 2 years.

• BDI-II

  Through study completion, an average of 2 years.

Study Arms (1)

Migraine Patients

Migraine patients who initiate a CGRP-targeted treatment

Drug: CGRP antibody or gepant

Interventions

CGRP antibody or gepant DRUG

Patients will start anti-CGRP or its receptor antibody or gepants

Migraine Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Episodic and chronic migraine patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (26)

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

RECRUITING

FLENI

Buenos Aires, Argentina

RECRUITING

Pontificia Universidad Católica de Chile

Santiago, Chile

RECRUITING

Neuromedica

Medellín, Colombia

RECRUITING

Special Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-Rovigno

Rovinj, Croatia

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

LMU University Hospital

München, Germany

RECRUITING

University of L'Aquila

L’Aquila, Italy

RECRUITING

University of Modena and Reggio Emilia

Modena, Italy

RECRUITING

National Neurological Institute C. Mondino Foundation

Pavia, Italy

RECRUITING

IRCCS San Raffaele

Roma, Italy

RECRUITING

Universiti Putra Malaysia

Serdang, Selangor, Malaysia

RECRUITING

Neuroclinic Norway

Lillestrøm, Norway

RECRUITING

Wrocław Medical University

Wroclaw, Poland

RECRUITING

Hospital Santa Maria Lisbon

Lisbon, Portugal

RECRUITING

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Fundació Sanitària Mollet

Mollet del Vallès, Barcelona, Spain

NOT YET RECRUITING

Hospital de Viladecans

Viladecans, Barcelona, Spain

RECRUITING

Hospital General Universitario de Albacete

Albacete, Spain

RECRUITING

Fundación Jiménez Díaz

Madrid, Spain

RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

La Paz University Hospital

Madrid, Spain

RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

RECRUITING

Mersin University

Mersin, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Calcitonin Gene-Related Peptide Receptor Antagonists

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Patricia Pozo-Rosich, MD, PhD

  Vall d'Hebron University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Pozo-Rosich, MD, PhD

CONTACT

(+34) 93 489 30 00; cefalea@vhir.org

Edoardo Caronna, MD, PhD

CONTACT

(+34) 93 489 30 00; cefalea@vhir.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: September 8, 2025
• Study Start: January 2, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1); CL (1); IT (4); US (1); DE (2); AR (1); CR (1); ES (10); PL (1); CO (1); NO (1); MY (1); PT (1)