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Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine
This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.
This is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled Phase III study, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment. participants will be randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo. The double-blind, placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of eptinezumab. The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks).
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
The First Medical Center of The Chinese PLA General Hospital (301 Hospital)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
Guangzhou, Guangdong, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University - Main Campus
Wuhan, Hubei, China
Beijing Chaoyang Hospital Capital Medical University
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
Beijing, China
The First Hospital of Jilin University
Changchun, China
The Second Norman Bethune Hospital of Jilin University - Ziqiang Campus
Changchun, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Start Date
May 29, 2021
Primary Completion Date
October 1, 2024
Completion Date
February 17, 2025
Last Updated
January 14, 2026
981
ACTUAL participants
Placebo
DRUG
Eptinezumab
DRUG
Lead Sponsor
H. Lundbeck A/S
NCT06641466
NCT07018713
NCT04715685
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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