Long-term Atogepant in Real-world Practice

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.

Conditions

• Migraine
• Headache
• Headache (Migraine)
• Migraine Disease
• Migraine Disorder
• Migraine Headache
• Migraine Disability

Interventions

DRUG

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.

OTHER

Headache diary

Patients systematically recorded monthly headache days, monthly migraine days, and use of acute medication throughout follow-up.

OTHER

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.

Sponsors & Collaborators

• Hospital Universitario de Fuenlabrada

  collaborator OTHER

• Fundación Jimenez Diaz de Madrid

  collaborator UNKNOWN

• Hospital Virgen del Puerto

  collaborator OTHER_GOV

• Hospital San Carlos, Madrid

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital Clínico Universitario de Valladolid

  collaborator OTHER

• Hospital Universitario Fundación Alcorcón

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Son Espases

  collaborator OTHER

• Hospital Clínico Universitario Lozano Blesa

  collaborator OTHER

• Hospital Universitario Getafe

  collaborator OTHER

• Hospital Torrejón de Ardoz

  collaborator UNKNOWN

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  lead OTHER

Principal Investigators

• Ana Belen Gago Veiga · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2026-03-01

Completion

2026-03-01

FDA Drug

Yes

Countries

• Spain

Study Locations