NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedMigraine
Date of first enrollment21/09/2021
Target sample size154
Countries of recruitment
Study typeInterventional
Intervention(s)Eptinezumab 100 mg or eptinezumab 300 mg administered intravenously

Outcome(s)

Primary OutcomeNumber of Participants With Adverse Events (AEs) from Baseline to Week 68
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 75age old
GenderBoth
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

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
E-mail 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
E-mail mnya@lundbeck.com
Affiliation Lundbeck Japan K.K.