A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Chinese Participants
2 other identifiers
interventional
787
1 country
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2023
Typical duration for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedStudy Start
First participant enrolled
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2025
CompletedJanuary 14, 2026
January 1, 2026
2.3 years
March 30, 2023
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from the Observation Phase (OP) in the number of migraine days per month over the entire Double Blind Treatment (DBT) Phase
The change from OP (up to 4 weeks) is calculated as the number of monthly migraine days during the 12 weeks of the DBT phase (Weeks 1 to 12) minus number of monthly migraine days during the OP (up to 4 weeks).
OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
Secondary Outcomes (10)
Proportion of participants with >= 50% reduction from the OP in the number of moderate to severe migraine days per month over the entire DBT Phase
OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
Mean change from the OP in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT Phase.
OP (up to 4 weeks) and Weeks 1-4 of the DBT phase
Mean change from the OP in the number of migraine days per month in the last 4 weeks (Weeks 9 to 12) of the DBT Phase.
OP (up to 4 weeks) and Weeks 9-12 of the DBT phase
Mean change from baseline in the MSQoL v2.1 role function - restrictive domain score at Week 12 of the DBT Phase
OP (up to 4 weeks) and Week 12 of the DBT phase
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.
Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
- +5 more secondary outcomes
Study Arms (2)
DBT Rimegepant/OLE Rimegepant
EXPERIMENTALDBT Phase (Weeks 1 through 12): Participants will receive a single oral dose of rimegepant orally disintegrating tablet (ODT) EOD for 12 weeks. OLE Phase (Weeks 13 through 24): Participants who continue to meet study entry criteria, will enter the OLE phase and receive a single oral dose of rimegepant ODT EOD for 12 weeks. If participants have a migraine on a day that they are not scheduled to dose with rimegepant, they can take one tablet of rimegepant ODT on that calendar day to treat a migraine (as needed \[PRN\] dosing).
DBT Placebo/OLE Rimegepant
PLACEBO COMPARATORDBT Phase (Weeks 1 through 12): Participants will receive a single oral dose of placebo matching to rimegepant ODT EOD for 12 weeks. OLE Phase (Weeks 13 through 24): Participants who continue to meet study entry criteria, will enter the OLE phase and receive a single oral dose of rimegepant ODT EOD for 12 weeks. If participants have a migraine on a day that they are not scheduled to dose with rimegepant, they can take one tablet of rimegepant ODT on that calendar day to treat a migraine (PRN dosing).
Interventions
Rimegepant
Eligibility Criteria
You may qualify if:
- Target Population: Participant has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4 to 72 hours if untreated
- Per participant report, 4 to18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)
- or more migraine days during Observation Phase
- Not more than 18 headache days during the Observation Phase
- Ability to distinguish migraine attacks from tension/cluster headaches.
- Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
You may not qualify if:
- Participant has a history of basilar migraine or hemiplegic migraine.
- Participants are excluded if they have had no therapeutic response with \> 2 of the 9 medication categories of preventive treatment of migraine after an adequate therapeutic trial in the past 3 years per investigator's judgement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (49)
The Second People's hospital of Hefei
Hefei, Anhui, 230011, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
The fourth people's hospital of chongqing
Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The 900th Hospital of Joint Logistics Support Force, PLA
Fuzhou, Fujian, 350025, China
Lanzhou university second hospital
Lanzhou, Gansu, 730030, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Hebei General Hospital
Shijiazhuang, Hebei, 050051, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450014, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215006, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Wuxi No. 2 People's Hospital
Wuxi, Jiangsu, 214043, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
The First hospital of Jilin University
Changchun, Jilin, 130000, China
The Second Hospital of Jilin University
Changchun, Jilin, 130000, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110067, China
General Hospital of Ningxia Medical Hospital
Yinchuan, Ningxia, 750003, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi, 712000, China
Shengli Oilfield Central Hospital
Dongying, Shandong, 257099, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000, China
Liaocheng people's Hospital
Liaocheng, Shandong, 252000, China
Linyi People's Hospital
Linyi, Shandong, 276034, China
Qingdao Central Hospital
Qingdao, Shandong, 266042, China
People's Hospital of Rizhao
Rizhao, Shandong, 276800, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The Second Affiliated hospital of Kunming Medical University
Kunming, Yunnan, 650000, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016, China
The First Affiliated Hosptial of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Peking University People's Hospital
Beijing, 100044, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, 046000, China
Chongqing University Three Gorges Hospital
Chongqing, 404000, China
Tianjin Union Medical Center
Tianjin, 300000, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2023
First Posted
April 12, 2023
Study Start
May 15, 2023
Primary Completion
August 25, 2025
Study Completion
December 10, 2025
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.