MigraineEUREkANCT07159750
Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
An observational study of Migraine and Episodic Migraine, run by Hospital Universitari Vall d'Hebron Research Institute at 26 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Episodic Migraine, Chronic Migraine, Headache
- What is being tested?
- CGRP antibody or gepant
- How many people
- 700 participants
- Where
- 26 sitesin 13 countries
- Study dates
- 2 Jan 2024to Jan 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Episodic and chronic migraine patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 13 countries
Spain10 sites, 10 recruiting
- Recruiting
Hospital General Universitario de Albacete
Albacete
Almudena Layos-Romero, (+34) 967 59 71 00, almudenalayos@gmail.com
- Recruiting
Germans Trias i Pujol Hospital
Badalona, Barcelona
Laura Dorado, MD, PhD, (+34)93 465 12 00, ldorado.germanstrias@gencat.cat
- Recruiting
Vall d'Hebron University Hospital
Barcelona, Barcelona, 08035
Patricia Pozo-Rosich, MD, PhD, (+34) 93 489 30 00 ext. 2479, cefalea@vhir.org
Edoardo Caronna, MD, PhD, (+34) 93 489 30 00 ext. 2479, cefalea@vhir.org
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Albert Muñoz-Vendrell, MD, PhD, (+34) 932 60 75 00, amunoz@bellvitgehospital.cat
- Recruiting
Fundación Jiménez Díaz
Madrid
Jaime Rodríguez Vico, MD, (+34)915 50 48 00, jaime.rvico@fjd.es
- Recruiting
Hospital Universitario Gregorio Marañón
Madrid
Alberto Lozano Ros, (+34) 915 86 80 00, alozanoros87@gmail.com
- Recruiting
La Paz University Hospital
Madrid
Javier Díaz de Terán, MD, PhD, (+34)917277233, javierddt@gmail.com
- Not yet recruiting
Fundació Sanitària Mollet
Mollet del Vallès, Barcelona
Teresa Mateu, MD, (+34)934893000 ext. 2479, teresa.mateu@vhir.org
- Recruiting
Hospital de Viladecans
Viladecans, Barcelona
Mariano Huerta, (+34) 936 59 01 11, mhuerta.hv@gencat.cat
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Sonia Santos Lasaosa, (+34) 976 76 57 00, ssantos@salud.aragon.es
Italy4 sites, 4 recruiting
- Recruiting
University of L'Aquila
L’Aquila
Simona Sacco, (+39) 0862 4311, simona.sacco@univaq.it
- Recruiting
University of Modena and Reggio Emilia
Modena
Luigi Iannone, (+39) 059 205 6511, iannone.luigifrancesco@gmail.com
- Recruiting
National Neurological Institute C. Mondino Foundation
Pavia
Cristina Tassorelli, (+39) 0382 3801, cristina.tassorelli@unipv.it
- Recruiting
IRCCS San Raffaele
Roma
Piero Barbanti, (+39) 06 660581, piero.barbanti@sanraffaele.it
Germany2 sites, 2 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin
Bianca Raffaelli, (+49) 30 45050, bianca.raffaelli@charite.de
- Recruiting
LMU University Hospital
München
Ruth Ruscheweyh, (+49) 89 440073800, ruth.ruscheweyh@med.uni-muenchen.de
United States1 site, 1 recruiting
- Recruiting
University of Miami, Miller School of Medicine
Miami, Florida, 33136
Teshamae S Monteith, 305-243-2010, tmonteith@med.miami.edu
Argentina1 site, 1 recruiting
- Recruiting
FLENI
Buenos Aires
María Teresa Goicochea, MD, (+54) 11 5777-3200, mtgoycochea@fleni.org.ar
Chile1 site, 1 recruiting
- Recruiting
Pontificia Universidad Católica de Chile
Santiago
Javiera Canales, (+56) 2 2633 2051, javieracanalesrodriguez@gmail.com
Colombia1 site, 1 recruiting
- Recruiting
Neuromedica
Medellín
Natalia Hernández, (+57) 304 6452119, hernandez.natalia12@gmail.com
Croatia1 site, 1 recruiting
- Recruiting
Special Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-Rovigno
Rovinj
Matija Sošić, (+385) 52 811 011, matija.sosic1@gmail.com
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Putra Malaysia
Serdang, Selangor
Wan Aliaa Wan Sulaiman, FRCP, (+60) 3-9769 1000, wanaliaa@upm.edu.my
Norway1 site, 1 recruiting
- Recruiting
Neuroclinic Norway
Lillestrøm
Christina Sundal, MD, PhD, (+47) 97 30 00 05, christinahsundal@gmail.com
Poland1 site, 1 recruiting
- Recruiting
Wrocław Medical University
Wroclaw
Marta Waliszewska-Prosół, MD, PhD, (+48) 71 784 12 07, marta.waliszewska@gmail.com
Portugal1 site, 1 recruiting
- Recruiting
Hospital Santa Maria Lisbon
Lisbon
Isabel Pavão Martins, MD, PhD, (+351) 21 780 5000, ipavaomartins@gmail.com
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin University
Mersin
Aynur Özge, (+90) 324 361 00 01, aynurozge@gmail.com
About this study
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.
Read the 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
- Being tested
- CGRP antibody or gepant
- Keywords
- Migraine, Prevention, Chronic Migraine, Episodic Migraine, galcanezumab, erenumab, fremanezumab, eptinezumab, rimegepant, atogepant
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGRP antibody or gepantDrug
Patients will start anti-CGRP or its receptor antibody or gepants
| Study group | Role | What they receive |
|---|---|---|
| Migraine Patients | Migraine patients who initiate a CGRP-targeted treatment Receives: Drug: CGRP antibody or gepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monthly Headache Days and Monthly Migraine Days
Measured: Through study completion, an average of 2 years
Secondary outcomes (10)
HIT-6
Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact.
Measured: Through study completion, an average of 2 years
MIDAS
Change in MIDAS (Migraine Disability Assessment Scale) scale, to assess disability attributed to migraine.
Measured: Through study completion, an average of 2 years
PGIC
PGIC (Patien Global Impression of Change) scale will be used to assess impression of change in migraine patients.
Measured: Through study completion, an average of 2 years.
BAI
Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients.
Measured: Through study completion, an average of 2 years.
BDI-II
Change in BDI-II (Beck's Depression Inventory, 2nd version) scale, to assess depression in migraine patients.
Measured: Through study completion, an average of 2 years.
MSQ Version 2.1
Changes in MSQ (Migraine-Specific Quality-of-Life) Version 2.1 scale, to assess patient's quality of life.
Measured: Through study completion, an average of 2 years.
WPAI
Changes in WPAI (Work Productivity and Activity Impairment) questionnaire, to assess how migraine impacts in work and productivity in migraine patients.
Measured: Through study completion, an average of 2 years.
ISI
Changes in ISI (Insomnia Severity Index) scale to assess insomnia in migraine patients.
Measured: Through study completion, an average of 2 years.
ASC-12
Changes in ASC-12 (Allodynia Symptom Checklist) scale, to assess allodynia in migraine patients.
Measured: Through study completion, an average of 2 years.
m-TOQ
m-TOQ (Migraine Treatment Optimization Questionnaire) scale will be used to assess the effectiveness of migraine treatment.
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Pozo-Rosich, MD, PhD, Principal investigator, Vall d'Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159750
- Sponsor's protocol ID
- EOM(AG)008/2024(6234)
- Acronym
- EUREkA
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
- ClinicalTrials.gov ID
- NCT07159750
- Acronym / sponsor ID
- EUREkA / EOM(AG)008/2024(6234)
- Conditions
- Migraine, Episodic Migraine, Chronic Migraine, Headache
- Keywords
- Migraine, Prevention, Chronic Migraine, Episodic Migraine, galcanezumab, erenumab, fremanezumab, eptinezumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraine Patients | – | Drug: CGRP antibody or gepantMigraine patients who initiate a CGRP-targeted treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Episodic and chronic migraine patients.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGRP antibody or gepantPatients will start anti-CGRP or its receptor antibody or gepants | Drug | Migraine Patients |
Primary outcome
Change in Monthly Headache Days and Monthly Migraine Days
Time frame: Through study completion, an average of 2 years
10 secondary outcomes
HIT-6
Time frame: Through study completion, an average of 2 years
MIDAS
Time frame: Through study completion, an average of 2 years
PGIC
Time frame: Through study completion, an average of 2 years.
BAI
Time frame: Through study completion, an average of 2 years.
BDI-II
Time frame: Through study completion, an average of 2 years.
MSQ Version 2.1
Time frame: Through study completion, an average of 2 years.
WPAI
Time frame: Through study completion, an average of 2 years.
ISI
Time frame: Through study completion, an average of 2 years.
ASC-12
Time frame: Through study completion, an average of 2 years.
m-TOQ
Time frame: Through study completion, an average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Pozo-Rosich, MD, PhD principal investigator
Vall d'Hebron University Hospital
26 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Episodic Migraine, run by Hospital Universitari Vall d'Hebron Research Institute at 26 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Spain, Italy, Germany, United States, Argentina and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Pozo-Rosich, MD, PhD ((+34) 93 489 30 00 ext. 2479, cefalea@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Monthly Headache Days and Monthly Migraine Days (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.