NCT04921384

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 981 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.

Detailed description

This is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled Phase III study, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment. participants will be randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo. The double-blind, placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of eptinezumab. The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks).

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Placebo	0.9% normal saline, intravenously
DRUG	Eptinezumab	Solution for infusion, intravenously

Timeline

• Start date: 2021-05-29
• Primary completion: 2024-10-01
• Completion: 2025-02-17
• First posted: 2021-06-10
• Last updated: 2026-01-14

Locations

87 sites across 8 countries: China, Georgia, Japan, Poland, Slovakia, South Korea, Spain, Taiwan