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COMPLETED
NCT05810038
PHASE3

A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.

Sponsor: Pfizer

View on ClinicalTrials.gov

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

DRUG

Rimegepant

Rimegepant

DRUG

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