Real-world use of anti-CGRP medicines for preventing migraine
Official title: Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
Run by Hospital Universitari Vall d'Hebron Research Institute · NCT07159750 · Data updated 2026-11-12
This project will follow people with episodic or chronic migraine who start anti-CGRP medicines to see if the treatments reduce migraine frequency and side effects over two years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Drugs / interventions | erenumab, galcanezumab, fremanezumab, eptinezumab |
| Locations | 26 sites (Miami, Florida and 25 other locations) |
| Status | Recruiting |
| Started | January 2, 2024 |
| Main results expected | January 2026 |
| Study ends | January 2026 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT07159750 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with episodic or chronic migraine who are prescribed an anti-CGRP monoclonal antibody (erenumab, galcanezumab, fremanezumab, eptinezumab) or a gepant (rimegepant, atogepant) and meet local reimbursement and consent requirements.
✕Probably not a fit
Patients whose headaches are not migraine, who have active severe psychiatric or cognitive impairment affecting consent, or who are not prescribed or reimbursed for anti-CGRP therapy locally would not benefit from or be eligible for this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a 2-year multicenter observational project that follows patients prescribed anti-CGRP monoclonal antibodies or gepants under routine care. Participants undergo a baseline assessment when treatment starts and return every six months to record treatment effectiveness, side effects, patient-reported outcome measures, and ongoing eligibility for the medication. Inclusion depends on a migraine diagnosis (ICHD-III) and meeting local prescriber and reimbursement criteria, with consent obtained before enrollment. No experimental interventions are assigned — treatments are given per clinicians' decisions and the study collects real-world data to compare outcomes across different anti-CGRP options.
Why it matters
Potential benefit: If successful, the results could help doctors and patients choose which anti-CGRP medicine is likely to work best or be better tolerated in routine practice.
How similar studies have gone: Randomized trials and accumulating real-world studies of anti-CGRP monoclonal antibodies and gepants have shown reductions in migraine frequency and acceptable tolerability, so this study extends that evidence into routine care settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University of Miami, Miller School of Medicine
Miami, Florida, 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
Show 20 more locations
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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, Spain Recruiting -
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain 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 -
Fundació Sanitària Mollet
Mollet del Vallès, Barcelona, Spain Not yet recruiting
Study contacts
- Principal investigator: Patricia Pozo-Rosich, MD, PhD — Vall d'Hebron University Hospital
- Study coordinator: Patricia Pozo-Rosich, MD, PhD
- Email: cefalea@vhir.org
- Phone: (+34) 93 489 30 00
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Analyzing CGRP Levels in Migraine Patients by Age and Sex
This study looks at the levels of a substance linked to migraines in people with migraines and healthy individuals to see how age and sex might affect treatment responses.
-
MMA Embolization for Migraine: Patient-Reported Outcomes from a Single Site
This registry tests whether adults with migraine who have or plan to have middle meningeal artery embolization notice changes in headaches and quality of life over time.
-
Bilateral middle meningeal artery embolization for refractory chronic migraine
This study will try blocking both middle meningeal arteries with Onyx in adults who have refractory bilateral chronic migraine to see if it is safe and lowers headaches.
-
New methods to test preventive migraine treatment
This trial will test how the active medicine, placebo injections, and the information given about them affect symptoms in adults with chronic migraine.
-
Nordic comparison of CGRP antibody plus onabotulinumtoxinA (Botox) versus CGRP antibody alone for chronic migraine
This trial will test whether adding onabotulinumtoxinA (Botox) to a CGRP monoclonal antibody reduces monthly headache days in adults with chronic migraine.
-
Assessing the safety and effectiveness of Atogepant for migraine prevention in Korean adults
This study is testing how well and safely Atogepant works for preventing migraines in Korean adults who have chronic or episodic migraines.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.