General Study Questions

Your child may or may not directly benefit from being in either clinical study. However, the information collected may help doctors learn more about treating other adolescents and teens with chronic migraine in the future.

Your child’s participation in either study will cost you nothing. Your child will receive the study medicine (or placebo) and have all the study tests at no cost to you. You may also be reimbursed for certain travel expenses to study visits.

The healthcare company H. Lundbeck A/S (Lundbeck) is sponsoring and running the PROSPECT-2 Study.

No, your child’s participation in the study is completely voluntary. If you and your child decide to join and then change your minds, your child can leave the study at any time.

Study Setup Questions

The PROSPECT-2 Study lasts about 16 weeks (4 months).

During the study, your child will visit the study site for tests and health checks about 3 to 4 times. You and your child will also have phone calls with the study team.

Study Treatment Questions

During the study, your child will be assigned by chance to receive either the study medicine, eptinezumab, or a placebo. The placebo looks like eptinezumab but contains no actual medicine. This gives researchers something to compare with the study medicine.

A computer is used to assign study participants to study treatment groups by chance, like dealing from a shuffled deck of cards. This is called randomization.

The study treatment is given as an infusion, which means slowly through a small needle into a vein. During the study, your child will receive a one-time infusion. The infusion takes about 30 minutes.

Investigational medicine means the medicine has been studied in a lab and is being studied in people but is currently not approved for use by regulatory agencies.

The placebo looks like eptinezumab but contains no active medicine. This gives researchers something to compare eptinezumab to in order to better understand its effects.

Like all medicines, there is a chance for side effects, which are unwanted and unintended effects from a medicine. Your child’s health will be closely monitored during the entire study. It is very important to tell the study doctor if you notice any changes in your child’s health or if anything is bothering him/her.