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

NCT05064371 — Phase 3, Completed, 160 participants, H. Lundbeck A/S

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

Registry	NCT05064371
Status	Completed
Phase	Phase 3
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	160 (Actual)
Sponsor	H. Lundbeck A/S (Industry)
Conditions	Migraine
Interventions	Eptinezumab (Drug)
Dates	start 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 in Japan

-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.

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+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).

+Arms and interventions

Arm	Type	Interventions	Description
Eptinezumab	Experimental	Drug: Eptinezumab	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.

Eptinezumab (Drug): Concentrate for solution for IV infusion

+Outcome measures

Primary outcomes

Number of Participants With Adverse Events (AEs) [From Baseline to Week 68]

Secondary outcomes

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]
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]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.
* 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.

+Locations (17)

Facility	City	Country
DOI Clinic Internal Medicine	Hiroshima-Shi Naka-Ku, Hiroshima	Japan
Jinnouchi Neurosurgery Clinic	Kasuga-Shi, Hukuoka	Japan
Ikeda Neurosurgical Clinic	Kasuga-Shi, Hukuoka	Japan
Mito Kyodo General Hospital	Mito, Ibaraki	Japan
Iwate Medical University Uchimaru Medical Center	Morioka, Iwate	Japan
Atsuchi Neurosurgery Hospital	Kagoshima, Kagoshima-ken	Japan
Shin Matsudakai Atago Hospital	Kochi, Kôti	Japan
Sendai Headache and Cranial Nerves Clinic	Sendai-Shi Taihaku-Ku, Miyagi	Japan
Saitama Neuropsychiatric Institute	Saitama-Shi, Saitama	Japan
Moriyama Neurological Center Hospital	Edogawa-Ku, Tokyo	Japan
Tokyo headache clinic	Shibuya-Ku, Tokyo	Japan
Nagamitsu Clinic	Hofu-Shi, Yamaguchi	Japan
Tatsuoka Neurology Clinic	Kyoto Shimojo-ku	Japan
Dokkyo Medical University Hospital	Mibu-machi	Japan
Japanese Red Cross Shizuoka Hospital	Shizuoka	Japan
Toyota Memorial Hospital	Toyota-shi	Japan
Tominaga Hospital	Osaka, Ã"saka	Japan

+Publications

Results publication: 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. PMID 41275111

+Investigators

Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com