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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | Concentrate for solution for IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From Baseline to Week 68 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Monthly Migraine Days | Baseline, Week 60 | |
| Response: Number of Participants With ≥50% Reduction From Baseline in Monthly Migraine Days (MMDs) | Baseline to Week 60 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DOI Clinic Internal Medicine | Hiroshima-Shi Naka-Ku | Hiroshima | 730-0031 | Japan | ||
| Jinnouchi Neurosurgery Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41275111 | Derived | Takeshima T, Danno D, Imai N, Suzuki K, Ettrup A, Jensen S, Josiassen MK, Mittoux A, Matsumori Y. Long-term tolerability and effectiveness of eptinezumab in Japanese adults with chronic migraine: results of the 60-week open-label SUNSET trial. J Headache Pain. 2025 Nov 22;26(1):275. doi: 10.1186/s10194-025-02214-w. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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| Change From Baseline in the Headache Impact Test (HIT-6) Score | Baseline, Week 60 |
| Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score | Baseline, Week 60 |
| Patient Global Impression of Change (PGIC) Score | Baseline to Week 60 |
| Change From Baseline in the Most Bothersome Symptom (MBS) Score | Baseline, Week 60 |
| Kasuga-Shi |
| Hukuoka |
| 816-0802 |
| Japan |
| Ikeda Neurosurgical Clinic | Kasuga-Shi | Hukuoka | 816-0824 | Japan |
| Mito Kyodo General Hospital | Mito | Ibaraki | 310-0015 | Japan |
| Iwate Medical University Uchimaru Medical Center | Morioka | Iwate | 020-0023 | Japan |
| Atsuchi Neurosurgery Hospital | Kagoshima | Kagoshima-ken | 892-0842 | Japan |
| Shin Matsudakai Atago Hospital | Kochi | Kôti | 780-0051 | Japan |
| Sendai Headache and Cranial Nerves Clinic | Sendai-Shi Taihaku-Ku | Miyagi | 982-0014 | Japan |
| Saitama Neuropsychiatric Institute | Saitama-Shi | Saitama | 338-8577 | Japan |
| Moriyama Neurological Center Hospital | Edogawa-Ku | Tokyo | 134-0085 | Japan |
| Tokyo headache clinic | Shibuya-Ku | Tokyo | 151-0051 | Japan |
| Nagamitsu Clinic | Hofu-Shi | Yamaguchi | 747-0802 | Japan |
| Tatsuoka Neurology Clinic | Kyoto Shimojo-ku | 680-8811 | Japan |
| Dokkyo Medical University Hospital | Mibu-machi | 321-0293 | Japan |
| Japanese Red Cross Shizuoka Hospital | Shizuoka | 420-0853 | Japan |
| Toyota Memorial Hospital | Toyota-shi | 471-8513 | Japan |
| Tominaga Hospital | Osaka | Ã"saka | 556-0017 | Japan |
| D009422 | Nervous System Diseases |