NCT05064371

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

Interventional, Open-label, Fixed-dose, Long-term Extension Study to Evaluate Safety of Eptinezumab as Preventive Treatment in Patients With Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open label extension study, which means that the participants from the Lead-in Study 19140A (NCT04921384) can join this study, if they meet the study Eligibility Criteria, and continue to receive the study drug eptinezumab. The main goal of this study is to investigate long-term safety and tolerability of eptinezumab in Japanese migraine participants.

Detailed description

The total study duration from the Baseline Visit to the Safety Follow-up Visit is approximately 68 weeks and includes an Open-Label Treatment Period (60 weeks) and a Safety Follow-up Period (8 weeks).

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Eptinezumab	Concentrate for solution for IV infusion

Timeline

• Start date: 2021-09-21
• Primary completion: 2024-06-08
• Completion: 2024-06-08
• First posted: 2021-10-01
• Last updated: 2026-01-14

Locations

17 sites across 1 country: Japan