A Phase 3 interventional study of Eptinezumab in Migraine, sponsored by H. Lundbeck A/S. Completed at 17 sites in Japan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment
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.
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).
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 160 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Participants will receive eptinezumab 100 milligrams (mg) at the Baseline visit (Week 0) and eptinezumab 100 mg or 300 mg (depending upon the treatment response) at Weeks 12, 24, 36, and 48 by intravenous (IV) infusions.
Drug: Eptinezumab
Concentrate for solution for IV infusion
Number of Participants With Adverse Events (AEs)
Time frame: From Baseline to Week 68
Change From Baseline in the Number of Monthly Migraine Days
Time frame: Baseline, Week 60
Response: Number of Participants With ≥50% Reduction From Baseline in Monthly Migraine Days (MMDs)
Time frame: Baseline to Week 60
Change From Baseline in the Headache Impact Test (HIT-6) Score
Time frame: Baseline, Week 60
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Time frame: Baseline, Week 60
Patient Global Impression of Change (PGIC) Score
Time frame: Baseline to Week 60
Change From Baseline in the Most Bothersome Symptom (MBS) Score
Time frame: Baseline, Week 60
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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H. Lundbeck A/S