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

NCT ID: NCT07159750

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-02

Study Completion Date

2026-01-31

Brief Summary

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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

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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

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Migraine Episodic Migraine Chronic Migraine, Headache

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Migraine Patients

Migraine patients who initiate a CGRP-targeted treatment

CGRP antibody or gepant

Intervention Type DRUG

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

Interventions

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CGRP antibody or gepant

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Pozo-Rosich, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron University Hospital

Locations

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University of Miami, Miller School of Medicine

Miami, Florida, United States

Site Status RECRUITING

FLENI

Buenos Aires, , Argentina

Site Status RECRUITING

Pontificia Universidad Católica de Chile

Santiago, , Chile

Site Status RECRUITING

Neuromedica

Medellín, , Colombia

Site Status RECRUITING

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

Rovinj, , Croatia

Site Status RECRUITING

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

LMU University Hospital

München, , Germany

Site Status RECRUITING

University of L'Aquila

L’Aquila, , Italy

Site Status RECRUITING

University of Modena and Reggio Emilia

Modena, , Italy

Site Status RECRUITING

National Neurological Institute C. Mondino Foundation

Pavia, , Italy

Site Status RECRUITING

IRCCS San Raffaele

Roma, , Italy

Site Status RECRUITING

Universiti Putra Malaysia

Serdang, Selangor, Malaysia

Site Status RECRUITING

Neuroclinic Norway

Lillestrøm, , Norway

Site Status RECRUITING

Wrocław Medical University

Wroclaw, , Poland

Site Status RECRUITING

Hospital Santa Maria Lisbon

Lisbon, , Portugal

Site Status RECRUITING

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain

Site Status RECRUITING

Vall d'Hebron University Hospital

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Fundació Sanitària Mollet

Mollet del Vallès, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Hospital de Viladecans

Viladecans, Barcelona, Spain

Site Status RECRUITING

Hospital General Universitario de Albacete

Albacete, , Spain

Site Status RECRUITING

Fundación Jiménez Díaz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

La Paz University Hospital

Madrid, , Spain

Site Status RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status RECRUITING

Mersin University

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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United States Argentina Chile Colombia Croatia Germany Italy Malaysia Norway Poland Portugal Spain Turkey (Türkiye)

Central Contacts

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Patricia Pozo-Rosich, MD, PhD

Role: CONTACT

(+34) 93 489 30 00 ext. 2479

Edoardo Caronna, MD, PhD

Role: CONTACT

(+34) 93 489 30 00 ext. 2479

Facility Contacts

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Teshamae S Monteith

Role: primary

305-243-2010

María Teresa Goicochea, MD

Role: primary

(+54) 11 5777-3200

Javiera Canales

Role: primary

(+56) 2 2633 2051

Natalia Hernández

Role: primary

(+57) 304 6452119

Matija Sošić

Role: primary

(+385) 52 811 011

Bianca Raffaelli

Role: primary

(+49) 30 45050

Ruth Ruscheweyh

Role: primary

(+49) 89 440073800

Simona Sacco

Role: primary

(+39) 0862 4311

Luigi Iannone

Role: primary

(+39) 059 205 6511

Cristina Tassorelli

Role: primary

(+39) 0382 3801

Piero Barbanti

Role: primary

(+39) 06 660581

Wan Aliaa Wan Sulaiman, FRCP

Role: primary

(+60) 3-9769 1000

Christina Sundal, MD, PhD

Role: primary

(+47) 97 30 00 05

Marta Waliszewska-Prosół, MD, PhD

Role: primary

(+48) 71 784 12 07

Isabel Pavão Martins, MD, PhD

Role: primary

(+351) 21 780 5000

Laura Dorado, MD, PhD

Role: primary

(+34)93 465 12 00

Patricia Pozo-Rosich, MD, PhD

Role: primary

(+34) 93 489 30 00 ext. 2479

Edoardo Caronna, MD, PhD

Role: backup

(+34) 93 489 30 00 ext. 2479

Albert Muñoz-Vendrell, MD, PhD

Role: primary

(+34) 932 60 75 00

Teresa Mateu, MD

Role: primary

(+34)934893000 ext. 2479

Mariano Huerta

Role: primary

(+34) 936 59 01 11

Almudena Layos-Romero

Role: primary

(+34) 967 59 71 00

Jaime Rodríguez Vico, MD

Role: primary

(+34)915 50 48 00

Alberto Lozano Ros

Role: primary

(+34) 915 86 80 00

Javier Díaz de Terán, MD, PhD

Role: primary

(+34)917277233

Sonia Santos Lasaosa

Role: primary

(+34) 976 76 57 00

Aynur Özge

Role: primary

(+90) 324 361 00 01

Other Identifiers

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EOM(AG)008/2024(6234)

Identifier Type: -

Identifier Source: org_study_id

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