JRCT ID: jRCT2071210060
Registered date:14/09/2021
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Migraine |
Date of first enrollment | 21/09/2021 |
Target sample size | 154 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Eptinezumab 100 mg or eptinezumab 300 mg administered intravenously |
Outcome(s)
Primary Outcome | Number of Participants With Adverse Events (AEs) from Baseline to Week 68 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 75age old |
Gender | Both |
Include 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. |
Exclude 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. |
Related Information
Primary Sponsor | Yazawa Masanari |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05064371 |
Contact
Public contact | |
Name | Takanori Narita |
Address | Nakanoshima Daibiru 16F 3-3-23 nakanoshima, Kita-ku, Osaka Osaka Japan 530-6116 |
Telephone | +81-80-8027-6361 |
Takanori.Narita@ppd.com | |
Affiliation | PPD-SNBL K.K. |
Scientific contact | |
Name | Masanari Yazawa |
Address | Kamiyacho Prime Place, 4-1-17 Toranomon, Minato-ku, Tokyo Tokyo Japan 105-0001 |
Telephone | +81-3-5733-8690 |
mnya@lundbeck.com | |
Affiliation | Lundbeck Japan K.K. |