Long-term Atogepant in Real-world Practice

This prospective multicentre observational study aims to evaluate the long-term effectiveness, safety, tolerability, and treatment persistence of atogepant for migraine prevention in routine clinical practice. Adult patients with migraine initiating atogepant across 15 tertiary Headache Units in Spain are followed for 12 months. Clinical outcomes, including monthly headache days, monthly migraine days, medication overuse, adverse events, treatment discontinuation, and patient-reported outcomes in a subset of participants, are assessed at baseline and after 3, 6, and 12 months. The study also characterizes different response trajectories, including sustained, delayed, and transient responses, in a real-world population with high disease burden and multiple prior preventive treatment failures.

NCT Number	NCT07699549
Lead Sponsor	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Collaborators: Hospital Universitario de Fuenlabrada, Fundación Jimenez Diaz de Madrid, Hospital Virgen del Puerto, Hospital San Carlos, Madrid, Hospital Universitario 12 de Octubre, Hospital Clínico Universitario de Valladolid, Hospital Universitario Fundación Alcorcón, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Paz, Hospital Son Espases, Hospital Clínico Universitario Lozano Blesa, Hospital Universitario Getafe, Hospital Torrejón de Ardoz
Conditions	Migraine, Headache, Headache (Migraine), Migraine Disease, Migraine Disorder, Migraine Headache, Migraine Disability
Enrollment	513 participants
Start Date	2024-06-01
Primary Completion	2026-03-01 (estimated)
Study Completion	2026-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-22