Long-term Atogepant in Real-world Practice

CompletedNCT07699549

View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title: Long-term Atogepant for Treatment-resistant Migraine in Real-world Clinical Practice: 12-month Result
Conditions: Migraine
Headache
Headache (Migraine)
Migraine Disease
Migraine Disorder
Migraine Headache
Migraine Disability
Interventions: Drug: Atogepant 60 mg
Other: Headache diary
Other: Patient-reported outcome measures
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
Start date: 2024-06-01
Primary completion: 2026-03-01
Sex: All
Age range: from 18 Years
Results posted: No results posted in this snapshot
Countries: Spain
Total sites listed: 1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07699549