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Long-term Atogepant in Real-world Practice
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Summary
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.
Official title: Long-term Atogepant for Treatment-resistant Migraine in Real-world Clinical Practice: 12-month Result
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
513
Start Date
2024-06-01
Completion Date
2026-03-01
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Atogepant 60 mg
Atogepant was administered as preventive treatment for migraine in routine clinical practice. Treatment initiation, dose selection, dose modifications, and discontinuation were determined by the treating physician according to the approved prescribing information and routine clinical practice. As this was an observational study, no study-specific intervention or randomization was performed.
Headache diary
Patients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up.
Patient-reported outcome measures
Patients completed standardized validated questionnaires including HIT-6, HADS, and ISI at predefined follow-up visits to assess migraine-related disability and associated comorbidities.
Locations (1)
Hospital Universitario de La Princesa
Madrid, Madrid, Spain