Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
NCT ID: NCT04574362
Last Updated: 2023-12-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1648 participants
INTERVENTIONAL
2020-10-22
2021-12-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rimegepant 75mg
One 75mg oral disintegration tablet
Rimegepant
One 75mg orally disintegrating tablet
Placebo
Matching placebo
Placebo
Matching placebo
Interventions
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Rimegepant
One 75mg orally disintegrating tablet
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
2. Migraine attacks, on average, lasting about 4-72 hours if untreated
3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
4. Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period
5. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.
6. Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study.
7. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion Criteria
2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
4. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
5. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
6. The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
8. Subjects are excluded if they have previously participated in any study of rimegepant or other experimental CGRP-antagonist study, or have been prescribed CGRP-antibodies within the last 6 months
9. Participation in any other investigational clinical trial while participating in this clinical trial
18 Years
ALL
No
Sponsors
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BioShin Limited
INDUSTRY
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 First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui provincal Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Lu'An People's Hospital
Lu'an, Anhui, China
The People's Hospital of Xuancheng City
Xuancheng, Anhui, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chonggang General Hospital
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Fujian medical University Union Hospital
Fuzhou, Fujian, China
The 900th Hospital of Joint Logistics Support Force, PLA
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Sun Yat-Sen Memorial Hospital of Zhongshan University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan, China
Hainan General Hospital
Haikou, Hainan, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Henan University of Science and Technology First Affiliated Hospital
Luoyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Zhengzhou People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Huanggang Central Hospital
Huanggang, Hubei, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Taihe Hospital
Shiyan, Hubei, China
Wuhan Fourth hospital
Wuhan, Hubei, China
Renmin Hospital Of Wuhan University
Wuhan, Hubei, China
Wuhan Third Hospital
Wuhan, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital Of Central South University
Changsha, Hunan, China
The Central Hospital of Shaoyang
Shaoyang, Hunan, China
The First People's Hospital of Yueyang
Yueyang, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Zigong First People's Hospital
Sichuan, Igong, China
The first affiliated hospital of Baotou medical college of Inner Mongolia university of science and technology
Baotou, Inner Mongolia, China
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital With Nanjing Medical University
Nanjing, Jiangsu, China
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Wuxi Integrated Traditional Chinese and Western Medicine Hospital
Wuxi, Jiangsu, China
Wuxi people's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
1st Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, China
General Hospital of Ningxia Medical Hospital
Yinchuan, Ningxia, China
Baoji Central Hospital
Baoji, Shaanxi, China
Xi'an Gaoxin Hospital Co., Ltd
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shaanxi Provincial People' Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, China
Yan'an University Xianyang Hospital Co., Ltd
Xianyang, Shaanxi, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Nankai University, Tianjin Union Medical Center
Tianjin, Tianjin Municipality, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
The Fifth Affiliated Hospital of Xinjiang Medical University
Xinjiang, Uramqi, China
People's Hospital of Xinjiang Uygur Autonomous Region
Xinjiang, Wulumuqi, China
The Second Affiliated Hospital of Xinjiang Medical University
Xinjiang, Wulumuqi, China
The Second Affiliated hospital of Kunming Medical University
Kunming, Yunnan, China
Ruian People's Hospital
Rui’an, Zhejiang, China
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Nowon Eulji Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ewha Womans University Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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References
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Yu S, Guo A, Wang Z, Liu J, Tan G, Yang Q, Zhang M, Yibulaiyin H, Chen H, Zhang Y, Croop R, Sun Y, Liu Y, Zhao Q, Lu Z. Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial. J Headache Pain. 2024 Apr 16;25(1):57. doi: 10.1186/s10194-024-01731-4.
Yu S, Kim BK, Guo A, Kim MH, Zhang M, Wang Z, Liu J, Moon HS, Tan G, Yang Q, McGrath D, Hanna M, Stock DA, Gao Y, Croop R, Lu Z. Safety and efficacy of rimegepant orally disintegrating tablet for the acute treatment of migraine in China and South Korea: a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2023 Jun;22(6):476-484. doi: 10.1016/S1474-4422(23)00126-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4951026
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3000-310
Identifier Type: -
Identifier Source: org_study_id