Researchers are studying ways to help children and teenagers who have migraines. This includes testing different medicines. In this study, the study drug being tested is called eptinezumab. Researchers want to learn more about what happens to the study drug inside the body of a child or teenager with migraines. Specifically, they want to know how much of the study drug is in a study participant’s blood after they take it, and how long it stays there. They will find this out by taking blood samples.
Researchers will also be looking at how the study drug works to help migraines, and what side effects (unwanted effects) it may cause.
To participate in this study, your child must:
- Be a male or female aged 6 to 17 years
- Have migraines that have been diagnosed by a doctor for at least 6 months
- Have had migraines at least 4 days per month for at least the past 3 months
There are other requirements for participating in this study, too. The study doctor will talk about all of them with children and teenagers interested in participating in this study, and their parent(s)/legal guardian(s).
This study has two parts: Part A and Part B. Part A will last about 6 months. After the 6 months, study participants will choose whether they want to stop participating in the study or keep participating in Part B.
Study participants who choose to participate only in Part A will have about 6 visits to the study center, plus a phone call.
Study participants who choose to participate in both Part A and Part B will be in the study for a total of about 1 year and 4 months. They will have about 10 visits to the study center, plus a phone call.
Everyone who participates in the study will start out in Part A.
In Part A, each participant will be given one dose of the study drug. It is given as an intravenous (IV) infusion, meaning that it goes through a small tube into a vein in the arm. During the visit, the infusion itself will take about a half hour and participants will be monitored for 2 hours after the infusion.
In Part B, participants will get up to 3 more infusions of the study drug: Month 5, Month 8, and Month 11.
Throughout both Part A and Part B, each participant will come to the study center even on days when they are not getting an infusion of the study drug so that the study doctor and nurses can do different health checks, tests (includes blood sampling), and see how the participant is feeling.
Study participants do not have to pay for the study drug, study supplies, study visits, or tests that are part of this research study. Compensation is available for time and travel.
It is possible for any drug, including study drugs being tested in research studies, to cause side effects, which are unwanted effects. The study doctor will talk about the risks of side effects with anyone who is interested in participating in this study, and their parent(s)/legal guardian(s).
Research studies are important for medical discoveries. The medicines that are now used to treat different diseases only exist because of research study participants.