Frequently Asked Questions
This study aims to gain additional knowledge about how you feel your life has been impacted since you started Vyepti® (eptinezumab-jjmr), and in general, to evaluate how participants like you feel Vyepti prevents migraine attacks in real life. If you are enrolled in this study, you will be asked about your health status as it pertains to your migraine condition as well as your experience with the infusion process with Vyepti. The information you provide will be very important in helping understand migraine care, and in improving care for people like you going forward.
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 will work closely with your infusion center (which will be compensated for facilitating the study) in case you have any questions about the study. ZS Associates and your infusion center constitute the study team in this document. For more information about ZS Associates, please visit https://www.zs.com.
Cisiv, a software company based in England, will host the study platform that will administer the surveys to study participants and collect their data. For more information about Cisiv, please visit https://www.cisiv.com.
Tremendous, an electronic compensation company, will provide an electronic gift card (eCard) to participants upon completion of each survey. For more information about Tremendous, please visit https://www.tremendous.com/.
The overall aim of this study is 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.
You can participate in this study if:
There may be other reasons why some people may not be able to participate. You will be asked about these when you take your first step toward enrollment.
- You are aged 18 years or older.
- You have not received an infusion of Vyepti before the time of your baseline (first) visit.
- You are NOT currently pregnant and have NO plans of getting pregnant in the next year (12 months).
- You live in the United States.
- You are willing to sign an informed consent document.
- You are able to read and understand English.
- You are willing to use your own device (smartphone, tablet, laptop, or computer) to complete surveys related to this study.
- You do not work for the infusion center or infusion center network, ZS Associates, or Lundbeck, and no family members do, either.
- You are NOT currently enrolled in a clinical trial about headache or migraine.
There may be other reasons why some people may not be able to participate. You will be asked about these when you take your first step toward enrollment.
Your participation in the study is expected to continue until December 31, 2030, assuming you wish to continue to participate in the study until then. You can choose to stop participating at any time.
During the study, you will be asked to complete surveys every 3 months to assess the impact of migraine and/or headache on your life. The first survey will take place before or within 24 hours of your first Vyepti infusion. The second survey will be completed approximately 7 days after the first infusion. The next surveys will be completed around your planned Vyepti infusion visits (every 3 months).
The first survey is estimated to take approximately 30 minutes. The remaining surveys should take about 20 minutes each 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.
The overall results of the study may be made public in international, scientific medical journals. Any public information about this study will include only the overall study results and not include any individual participant’s data, which means that your personal data will not be included in any such publications.
Personal information will be collected during this study directly from you and from your Vyepti referral form in accordance with the Clinical Study Plan. Your records will be key-coded with a randomly generated identification number that will be used to identify and link your record for all visits. The study team will maintain your name together with the random identification number, but no personal information about you will be shared with the study Sponsor (Lundbeck); all survey responses provided to the Sponsor will contain only the randomly assigned code.
The study team may also share information that is identifiable to you with certain parties in order to conduct the study appropriately, effectively, and in accordance with applicable laws and regulations. Those parties are:
While every effort will be made to protect the confidentiality of your information, absolute confidentiality cannot be guaranteed.
The study team may also share information that is identifiable to you with certain parties in order to conduct the study appropriately, effectively, and in accordance with applicable laws and regulations. Those parties are:
- People who work with the sponsor: ZS Associates (https://www.zs.com)
- Government agencies, such as Food and Drug Administration and regulatory authorities in other countries
- The Institutional Review Board (IRB) that reviewed the plan for this research
- The eCard vendor Tremendous who will email the link to the gift card to study participants (https://www.tremendous.com/)
- The study platform vendor: Cisiv
- Your referring healthcare provider, if you provide consent
While every effort will be made to protect the confidentiality of your information, absolute confidentiality cannot be guaranteed.
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.
As a study participant, you commit to the following:
- Be willing to use the secure study website or app on your own smartphone, iPad, tablet, or computer.
- Complete the first survey prior to your first infusion or within 24 hours from the start of that infusion, complete the second survey within one week (7 days) of that first infusion, and then subsequent surveys approximately every three months around your infusions, for a total of approximately 25 surveys over 6 years.
Your participation in this research will be kept strictly confidential. This means that only people who need to know will be aware you are taking part in the study and will have access to your personal information. The sponsor will only have access to anonymized data. In other words, the sponsor will not be able to identify you or your data and will not contact you.
Yes, the study has been reviewed and approved by an institutional review board (IRB), which is an independent committee that helps protect the rights of participants. If you have any questions about your rights as a participant, you may contact:
- By mail: Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044 - or call toll free: 877-992-4724
- or by email: adviser@advarra.com
No, to participate in this study, you will need a smartphone, iPad, tablet, or computer.
No, to participate in this study, you will need a valid email address that you access on a regular basis.
Yes, the study team or the sponsor can also remove you from the study at any time for any of the following reasons:
- If you do not complete the first survey prior to or within 24 hours of the start of your first Vyepti infusion;
- If it is discovered that you do not meet the study requirements;
- If the study is cancelled; or
- For administrative reasons.
On a periodic basis, you will receive information from your completed surveys, which you may choose to share with your treating healthcare provider if you wish.
If you provide consent, the study team may also share a summary of your survey results with your prescribing healthcare provider.
Because this is a non-interventional, observational study, participating is not expected to add risks beyond your usual care. However, Vyepti can cause side effects. Talk with your healthcare provider about the benefits and risks of Vyepti and read the Prescribing Information and Patient Package Insert. You will receive standard treatment with Vyepti, as decided with your healthcare provider, during your participation in the study. Your treatment will not change in any way as a result of participating in this study.