Study to Assess the Safety and Effectiveness of IV Eptinezumab for Preventing Chronic Migraine in Adolescents Aged 12 to 17 Years

What this Trial Is About

Researchers are evaluating whether eptinezumab can reduce the number of migraine days compared to a placebo in adolescents aged 12 to 17 with chronic migraine. This Phase 3, randomized, double-blind study aims to assess the preventive treatment effects of intravenous eptinezumab in this young population who experience frequent migraines. Participants will be randomly assigned to receive a single intravenous infusion of either eptinezumab 300 mg, eptinezumab 100 mg both doses adjusted by body weight, or a placebo. The study includes a 4-week screening period, followed by a 12-week double-blind treatment phase and an 8-week safety follow-up period. The doses are designed to target adult exposure levels based on weight. During the study, participants will complete a headache electronic diary to track migraine and headache days. Researchers will monitor changes in monthly migraine days over 12 weeks as the primary outcome. Additional assessments include migraine reduction percentages, medication usage, headache severity, disability scores, and blood tests for drug levels and antibodies. Safety and tolerability will be evaluated through the follow-up period, totaling about 24 weeks of participation.

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine