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.

Inclusion Criteria: * Adults aged ≥18 years. * Diagnosis of migraine with or without aura established by a headache specialist according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), including both chronic and episodic migraine. * History of migraine of at least 1 year duration. * Stable preventive migraine treatment (if any) for at least the previous 3 months. * Normal neurological examination. * Fulfilment of national health system reimbursement criteria for atogepant treatment. Exclusion Criteria: * Cognitive impairment or any other condition that, in the investigator's opinion, may prevent the patient from reliably distinguishing prodromal symptoms. * Presence of other active primary or secondary headache disorders, except medication overuse headache or infrequent tension-type headache.