About the Study

You may have been invited to join The Vyepti® (eptinezumab-jjmr) Real-World Effectiveness Study if your healthcare provider has prescribed Vyepti as new therapy for the preventive treatment of migraine. This study aims to gain additional knowledge about how you feel your life has been impacted since you started Vyepti, and in general, to evaluate how participants like you feel Vyepti prevents migraine attacks in real life.

Participation in the study is voluntary. You do not have to participate in the study if you do not want to. If you are pregnant or planning to become pregnant in the next 12 months, you are not eligible to participate in this study at this time.

If you decide not to participate in the study, it will not affect your care in any way. If you agree to take part, you can change your mind and decide to stop your participation in the study at any time.

The study is a participant survey study which means that it does not involve extra visits outside of your usual care. To participate, you will need a smartphone, iPad, tablet, or computer which you will use to answer survey questions in a secure study platform.

The surveys will ask about your health status as it pertains to your migraine condition, how your migraine and/or headaches impact your quality of life, as well as your experience with the infusion process with Vyepti.

Only research associates from the study team will have access to your survey responses. The sponsor (i.e., Lundbeck) will only have access to the responses in key-coded (de-identified) form, without any indication that those are responses from you as opposed to another study participant. So, the sponsor will not be able to identify you and will not contact you.

NOTE: The scientific value of the study will rely on your ability to respond to the survey questions to the best of your knowledge. You will receive reminders to complete your surveys on time.

The sponsor of the study is Lundbeck, the manufacturer of Vyepti. Lundbeck is a Danish international pharmaceutical company with over 100 years of history. It is headquartered in Copenhagen, Denmark. For more information about Lundbeck, please visit https://www.lundbeck.com/global.

The study will be administered by the clinical research division of ZS Associates, a consulting firm headquartered in Evanston, IL, with over 12,000 associates worldwide. ZS Associates and the participant’s infusion center constitute the study team in this document.

The study is being conducted within the United States (US), and we expect around 1500 patients to participate in this study.

If you are enrolled in the study, which is expected to continue until December 31, 2030 (if you choose to continue to participate), you will be asked to complete questionnaires on migraine and/or headache’s impact on your life. The first questionnaire takes place before your first Vyepti infusion or within 24 hours from when your infusion began. This baseline survey will take about 30 minutes to complete. The second survey will be filled out approximately 7 days after the first infusion, and the next surveys will be completed around each planned Vyepti infusion visit (about every 3 months). After the baseline survey, these follow-up questionnaires should take about 20 minutes to complete. To compensate for your time, you will be emailed a link for an electronic gift card (eCard) in the amount of $55 upon completion of the baseline (first) survey, and $35 upon completion of each of the additional surveys. The total amount you can receive depends on how many surveys you complete during the study (up to 25 surveys). These surveys all need to be completed within the specified timeframe for each survey. You will receive reminders before the survey is due.

You can change your mind about being in the study at any time. If you decide you no longer want to be in the study, you must either sign into the study platform (via app or web browser) and click on the “Withdraw Consent” button or contact your local study team and inform them that you wish to withdraw.

Data collected from all participants in this study will be analyzed for trends and other findings regarding the effectiveness of Vyepti and the infusion process. Before publishing any data from the study, the names and other indicators of the identity of each of the participants in that data will be replaced with a randomly assigned code. Therefore, in any publications related to the study, your name and identity will not be revealed; only the overall study results will be published.