A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.
NCT ID: NCT05810038
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
787 participants
INTERVENTIONAL
2023-05-15
2025-12-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DBT Rimegepant/OLE Rimegepant
DBT 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).
Rimegepant
Rimegepant
DBT Placebo/OLE Rimegepant
DBT 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).
Rimegepant
Rimegepant
Placebo
matching placebo
Interventions
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Rimegepant
Rimegepant
Placebo
matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4 to 72 hours if untreated
3. 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)
4. 6 or more migraine days during Observation Phase
5. Not more than 18 headache days during the Observation Phase
6. Ability to distinguish migraine attacks from tension/cluster headaches.
7. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion Criteria
2. 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
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Other Identifiers
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BHV3000-319
Identifier Type: OTHER
Identifier Source: secondary_id
C4951019
Identifier Type: -
Identifier Source: org_study_id
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