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A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the effects of Rimegepant to help prevent migraine. This study is seeking for participants who: * Are male and female of 18 years of age or older. * Have at least 1 year history of migraine . * Did not take any medication for migraine before the start of this study. The study will go on for around 30 weeks, including 4 Phases and 11 Visits. Participants who are selected for the study will be randomly assigned to treatment groups. After which, the participants will enter a 12-week Double-blind Treatment (DBT) Phase. After finishing the DBT Phase, some selected participants may enter a 12-week Open-label Extension (OLE) Phase. Participants will come back to the study site at the end of Week 24 for the End of Treatment (EOT) Visit. There will be a follow-up Week 2 Visit around 14 days after the EOT visit. Participants will be asked to take 1 tablet of study medicine every other calendar day. This need to be followed regardless of whether they have a migraine on that day or not. During the OLE Phase only, if a participant has a migraine on a non-scheduled dosing day, they may take 1 tablet of Rimegepant orally disintegrating tablet (ODT) as acute treatment for their migraine, if needed, with a maximum of 1 tablet of Rimegepant per calendar day. The study team will look at how each participant is doing with the study treatment during the regular visits at the study clinic.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Chinese Participants
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
787
Start Date
2023-05-15
Completion Date
2025-12-10
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
Rimegepant
Rimegepant
Placebo
matching placebo
Locations (49)
The Second People's hospital of Hefei
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The fourth people's hospital of chongqing
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The 900th Hospital of Joint Logistics Support Force, PLA
Fuzhou, Fujian, China
Lanzhou university second hospital
Lanzhou, Gansu, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
Hebei General Hospital
Shijiazhuang, Hebei, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Wuxi No. 2 People's Hospital
Wuxi, Jiangsu, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
General Hospital of Ningxia Medical Hospital
Yinchuan, Ningxia, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi, China
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Liaocheng people's Hospital
Liaocheng, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
People's Hospital of Rizhao
Rizhao, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second Affiliated hospital of Kunming Medical University
Kunming, Yunnan, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hosptial of Wenzhou Medical University
Wenzhou, Zhejiang, China
Peking University People's Hospital
Beijing, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, China
Chongqing University Three Gorges Hospital
Chongqing, China
Tianjin Union Medical Center
Tianjin, China