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

Interventional, open-label, flexible-dose, long-term extension study to evaluate safety of eptinezumab as preventive treatment in patients with migraine in Japan

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071210060
Enrollment
154
Registered
2021-09-14
Start date
2021-09-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Interventions

Eptinezumab 100 mg or eptinezumab 300 mg administered intravenously

Sponsors

Yazawa Masanari
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Number of Participants With Adverse Events (AEs) from Baseline to Week 68

Contacts

Public ContactTakanori Narita

PPD-SNBL K.K.

Takanori.Narita@ppd.com+81-80-8027-6361

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026