NCT05064371CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 22 Sept 2021
- Start date
- 21 Sept 2021
- Primary completion date
- 8 Jun 2024
- Lead sponsor
- H. Lundbeck A/S
- Diseases
- Migraine
- NCT number
- NCT05064371
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 160
- From 21 Sept 2021 to the primary completion date, 8 Jun 2024
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- The participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
- Other inclusion and exclusion criteria may apply.
Other
- The participant has a serious adverse event (SAE) or a moderate or severe ongoing AE from the Lead-In study considered a potential safety risk by the investigator.
- The participant has a clinically relevant change in vital signs or electrocardiogram (ECG) from the Lead-In study considered a potential safety risk by the investigator.
Who the study is looking for
- The participant has completed the Primary Outcome Visit (Visit 5) of the lead-in Study 19140A immediately prior to enrolment into this study.
- The participant is indicated for 60-week preventive treatment of chronic migraine with eptinezumab according to the clinical opinion of the investigator.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moriyama Neurological Center Hospital Coordinator of this site? Confirm its status | Edogawa-ku | Japan | Unknown status |
| DOI Clinic Internal Medicine Coordinator of this site? Confirm its status | Hiroshima-Shi Naka-Ku | Japan | Unknown status |
| Nagamitsu Clinic Coordinator of this site? Confirm its status | Hofu-shi | Japan | Unknown status |
| Atsuchi Neurosurgery Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Jinnouchi Neurosurgery Clinic Coordinator of this site? Confirm its status | Kasuga-shi | Japan | Unknown status |
| Ikeda Neurosurgical Clinic Coordinator of this site? Confirm its status | Kasuga-shi | Japan | Unknown status |
| Shin Matsudakai Atago Hospital Coordinator of this site? Confirm its status | Kochi | Japan | Unknown status |
| Tatsuoka Neurology Clinic Coordinator of this site? Confirm its status | Kyoto Shimojo-ku | Japan | Unknown status |
| Dokkyo Medical University Hospital Coordinator of this site? Confirm its status | Mibu-Machi | Japan | Unknown status |
| Mito Kyodo General Hospital Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Iwate Medical University Uchimaru Medical Center Coordinator of this site? Confirm its status | Morioka | Japan | Unknown status |
| Tominaga Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Saitama Neuropsychiatric Institute Coordinator of this site? Confirm its status | Saitama-shi | Japan | Unknown status |
| Sendai Headache and Cranial Nerves Clinic Coordinator of this site? Confirm its status | Sendai-Shi Taihaku-Ku | Japan | Unknown status |
| Tokyo Headache Clinic Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Unknown status |
| Japanese Red Cross Shizuoka Hospital Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Toyota Memorial Hospital Coordinator of this site? Confirm its status | Toyota-shi | Japan | Unknown status |
Related publications
- 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 · PMID 41275111
This page is information, not medical advice. Discuss any trial with your doctor.