Study of Intravenous Eptinezumab for Preventing Episodic Migraine in Children and Teens Aged 6 to 17 Years

What this Trial Is About

Researchers are evaluating whether eptinezumab can reduce the number of days with episodic migraine in children and adolescents aged 6 to 17 years. This Phase 3 clinical trial focuses on the preventive treatment of episodic migraine in pediatric participants using intravenous infusion. The study is randomized, double-blind, and placebo-controlled to compare the effects of different doses of eptinezumab with a placebo. Participants will be assigned to one of three groups a single intravenous infusion of eptinezumab 300 mg adjusted for weight, a single intravenous infusion of eptinezumab 100 mg adjusted for weight, or a single intravenous infusion of a placebo matching eptinezumab. The dosing occurs once, and the study monitors results over subsequent weeks. This design allows for comparison of the medication against placebo to evaluate treatment effects in this population. During the study, participants and their caregivers will complete headache diaries to document migraine and headache days. Researchers will assess changes in the number of monthly migraine days over 12 weeks, response rates to treatment, headache duration and intensity, acute medication use, and disability related to migraine using questionnaires like the Pediatric Migraine Disability Assessment PedMIDAS. Blood samples will be collected to measure drug concentrations and antibodies. Safety and efficacy are monitored throughout the study period, which concludes approximately 12 weeks after dosing.

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine