Status:

RECRUITING

Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine

Lead Sponsor:

AbbVie

Conditions:

Migraine

Eligibility:

All Genders

18+ years

Brief Summary

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate the effectiveness of ...

Eligibility Criteria

Inclusion

  • At least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD)-3, 2018.
  • Prescribed atogepant according to the relevant approved local label.
  • For participants who initiate atogepant at the prescribing physician or treating health care provider (HCP) discretion as part of their routine clinical care, the decision to administer atogepant must be made prior to and independent of recruitment into the study.
  • Willing and able to comply with the requirements of the study.
  • Not on concomitant preventive medication for migraine or have been on a stable preventive medication for migraine for at least 3 months prior to enrollment in the study. If on a stable preventive medication, the prescribing physician or treating HCP and participant must confirm that there is no plan to change concomitant preventive medication during the first 12 weeks of the study.

Exclusion

  • Previously exposed to atogepant as routine therapy or from clinical trials experience prior to entry.
  • Contraindications to atogepant as per local labeling.
  • Pregnant or planning to be pregnant or women of childbearing potential not using contraception.
  • Enrolled in any interventional studies that may include investigational compounds for migraine, or non-AbbVie observational studies.
  • In the opinion of the prescribing physician or treating HCP, the participant has a history or current evidence of any condition that might interfere with patient's ability to comply with the study requirements.

Key Trial Info

Start Date :

November 26 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2029

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT06543914

Start Date

November 26 2024

End Date

February 1 2029

Last Update

December 24 2025

Active Locations (107)

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Page 1 of 27 (107 locations)

1

Neurology and Neurodiagnostics of Alabama /ID# 267614

Hoover, Alabama, United States, 35244

2

Rehabilitation & Neurological Services /ID# 267612

Huntsville, Alabama, United States, 35805-4046

3

Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 267610

Phoenix, Arizona, United States, 85013

4

Kenneth Martinez MD, A Medical Corp /ID# 267834

Aliso Viejo, California, United States, 92656