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ong-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japa

Phase 3
Conditions
Migraine
Registration Number
JPRN-jRCT2071210060
Lead Sponsor
Yazawa Masanari
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
154
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

- 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umber of Participants With Adverse Events (AEs) from Baseline to Week 68
Secondary Outcome Measures
NameTimeMethod
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