Long-term Extension Study of Eptinezumab Treatment for Children and Teens Ages 6 to 17 With Chronic or Episodic Migraine

What this Trial Is About

Researchers are evaluating the long-term safety of eptinezumab in children and adolescents aged 6 to 17 years who have chronic or episodic migraine. This phase 3 extension study includes participants who completed prior lead-in studies focused on migraine treatment in this age group. The study aims to monitor how well eptinezumab is tolerated over an extended period in young migraine patients. Participants receive eptinezumab intravenously in one of two dose groups, either 100 mg or 300 mg adjusted by weight. Those who were previously assigned to these doses in the lead-in studies will continue the same dose, while those previously on placebo will be randomly assigned to one of the two doses. Each participant receives three infusions at Weeks 0, 12, and 24 during the open-label extension period. During the study, participants undergo regular assessments including safety evaluations, blood tests for drug levels and antibodies at multiple time points up to Week 44, and migraine disability questionnaires at Weeks 12, 24, and 36. The main outcome is the number of participants experiencing treatment-emergent adverse events. This study runs through April 2028, with ongoing monitoring to ensure participant safety and collect detailed data on treatment effects in this population.

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine