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NCT05810038CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
787 (actual)
First submitted
30 Mar 2023
Start date
15 May 2023
Primary completion date
25 Aug 2025
Lead sponsor
Pfizer
Diseases
Migraine
NCT number
NCT05810038

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 787
  • From 15 May 2023 to the primary completion date, 25 Aug 2025
  • 49 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Participant has a history of basilar migraine or hemiplegic migraine.

Who the study is looking for

  • 1.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)
  • 6 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (49)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Baotou Medical College
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BaotouChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
Chinese PLA General Hospital
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
The Second Hospital of Jilin University
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ChangchunChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
The Third Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Heping Hospital Affiliated to Changzhi Medical College
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ChangzhiChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
The fourth people's hospital of chongqing
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ChongqingChinaUnknown status
Chongqing University Three Gorges Hospital
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ChongqingChinaUnknown status
Shengli Oilfield Central Hospital
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DongyingChinaUnknown status
The 900th Hospital of Joint Logistics Support Force, PLA
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FuzhouChinaUnknown status
Guangzhou First People's Hospital
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GuangzhouChinaUnknown status
Hainan General Hospital
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HaikouChinaUnknown status
Sir Run Run Shaw Hospital
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HangzhouChinaUnknown status
The Second People's Hospital of Hefei
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HefeiChinaUnknown status
Qilu Hospital of Shandong University
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JinanChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Affiliated Hospital of Jining Medical University
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JiningChinaUnknown status
The Second Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Lanzhou University Second Hospital
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LanzhouChinaUnknown status
The Second People's Hospital of Lianyungang
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LianyungangChinaUnknown status
Liaocheng People's Hospital
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LiaochengChinaUnknown status
Linyi People's Hospital
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LinyiChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown status
Pingxiang People's Hospital
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PingxiangChinaUnknown status
Qingdao Central Hospital
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QingdaoChinaUnknown status
People's Hospital of Rizhao
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RizhaoChinaUnknown status
Shanghai East Hospital
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ShanghaiChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
The People's Hospital of Liaoning Province
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ShenyangChinaUnknown status
Hebei General Hospital
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ShijiazhuangChinaUnknown status
The First Affiliated Hospital of Suzhou University
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SuzhouChinaUnknown status
The Second Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
The First Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
Tianjin Union Medical Center
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TianjinChinaUnknown status
The First Affiliated Hosptial of Wenzhou Medical University
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WenzhouChinaUnknown status
Renmin Hospital of Wuhan University
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WuhanChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
Wuxi No.2 People's Hospital
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WuxiChinaUnknown status
Shaanxi provincial people's hospital
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Xi'anChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Xianyang Hospital of Yan'an University
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XianyangChinaUnknown status
Subei People's Hospital of Jiangsu province
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YangzhouChinaUnknown status
General Hospital of Ningxia Medical Hospital
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YinchuanChinaUnknown status
People's Hospital of Zhengzhou
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ZhengzhouChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.