Real-world use of anti-CGRP medicines for preventing migraine
Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
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 |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| 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) |
| Trial ID | NCT07159750 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida and 25 other locations
- 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)
- 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)
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.