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

Launched by ABBVIE · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called atogepant for treating migraines in adults. Migraines are severe headaches that can come with symptoms like nausea and sensitivity to light and sound. The trial will include about 1,000 adults who have been prescribed atogepant by their doctors, and it will take place over two years to see how well the medication works in real-life situations.

To be eligible for this study, participants need to have a history of migraines for at least a year and should be starting atogepant as part of their regular treatment plan. They should not be on other preventive migraine medications or have previously used atogepant. Participants will take the medication as prescribed and will have regular check-ups at their healthcare provider's office, but there won't be any extra burden on them beyond their usual care. Overall, this study aims to gather valuable information about how atogepant helps people manage their migraines in everyday life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.