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
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Baotou Medical College Coordinator of this site? Confirm its status | Baotou | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Heping Hospital Affiliated to Changzhi Medical College Coordinator of this site? Confirm its status | Changzhi | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The fourth people's hospital of chongqing Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing University Three Gorges Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Shengli Oilfield Central Hospital Coordinator of this site? Confirm its status | Dongying | China | Unknown status |
| The 900th Hospital of Joint Logistics Support Force, PLA Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Guangzhou First People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Hainan General Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second People's Hospital of Hefei Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| The Second Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| The Second People's Hospital of Lianyungang Coordinator of this site? Confirm its status | Lianyungang | China | Unknown status |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| Linyi People's Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Qingdao Central Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| People's Hospital of Rizhao Coordinator of this site? Confirm its status | Rizhao | China | Unknown status |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The People's Hospital of Liaoning Province Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Hebei General Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| The First Affiliated Hospital of Suzhou University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| The First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Union Medical Center Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hosptial of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Wuxi No.2 People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Shaanxi provincial people's hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Xianyang Hospital of Yan'an University Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| Subei People's Hospital of Jiangsu province Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
| General Hospital of Ningxia Medical Hospital Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.