NCT04965675

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

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Detailed description

The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.

Conditions

• Chronic Migraine in Children

Interventions

Type	Name	Description
DRUG	Eptinezumab	Eptinezumab will be administered per dose and schedule specified in the arm.
DRUG	Placebo	Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Timeline

• Start date: 2021-06-30
• Primary completion: 2026-09-05
• Completion: 2026-10-31
• First posted: 2021-07-16
• Last updated: 2026-03-12

Locations

84 sites across 11 countries: United States, Argentina, Canada, Italy, Mexico, Poland, Portugal, Serbia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study