Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
- Registration Number
- NCT04574362
- Lead Sponsor
- Pfizer
- Brief Summary
This trial is to determine whether BHV3000 (rimegepant) 75mg is safe and effictive as a treatment for acute migraine in Chinese and Korean patients
- Detailed Description
Biohaven Pharmaceuticals, Inc. is the agent for BioShin Limited, the sponsor of the studies in China and Korea.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1648
Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version including the following:
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
- Migraine attacks, on average, lasting about 4-72 hours if untreated
- Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
- 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
- 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.
- 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.
- Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Key
- Subject with a history of HIV disease
- 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
- 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)
- 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.
- 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
- 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.
- 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.
- 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
- Participation in any other investigational clinical trial while participating in this clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo Rimegepant 75mg Rimegepant One 75mg oral disintegration tablet
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose 2 hours post-dose MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS. Exact 95% CI was based on Clopper-Pearson method.
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose 2 hours post-dose Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (no pain) were considered to have freedom from pain. Exact 95 percent (%) confidence interval (CI) was based on Clopper-Pearson method.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose 2 to 48 hours post-dose Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 48 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method.
Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose 15, 30, 45, 60 and 90 minutes post-dose Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Percentage of participants who reported a pain level of moderate or severe just before taking study treatment and then reported a pain level of none at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method.
Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose 15, 30, 45, 60 and 90 minutes post-dose MBS included nausea, phonophobia or photophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS at the specified timepoints. Exact 95% CI was based on Clopper-Pearson method.
Percentage of Participants With Pain Relief at 2 Hours Post-dose 2 hours post-dose Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants who reported a pain level of moderate or severe at baseline and then reported a pain level of none or mild at 2 hours post-dose, were considered to have pain relief. Exact 95% CI was based on Clopper-Pearson method.
Percentage of Participants Who Functioned Normally at 2 Hours Post-dose 2 hours post-dose Participants rated the level of disability they perceived as a result of their migraine in performing normal actions using following level of severity: normal function, mild impairment, severe impairment, or required bedrest. This outcome measure was analyzed only among those participants who reported any impairment at baseline. Percentage of participants with a response of "normal function" at the 2 hours post-dose were reported in this outcome measure.
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose 24 hours post-dose Percentage of participants who used rescue medications within 24 hours of administration of study drug were reported in this outcome measure. Exact 95% CI was based on Clopper-Pearson method.
Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose 2 to 24 hours post-dose Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (with no pain) through 2 to 24 hours post-dose were considered to have sustained pain freedom. Exact 95% CI was based on Clopper-Pearson method.
Percentage of Participants With Pain Relapse 2 Hours to 48 Hours Post-dose Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. This outcome measure was analyzed only in those participants who were pain free at 2 hours post-dose. Percentage of participants who were pain free at 2 hours post-dose and then had a migraine of any pain severity (score 2 or 3 on the 4-point scale) within 48 hours after administration of study drug were considered to have pain relapse. Exact 95% CI was based on Clopper-Pearson method.
Trial Locations
- Locations (90)
1st Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shandong Provincial Qianfoshan Hospital
🇨🇳Jinan, Shandong, China
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Ewha Womans University Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Nowon Eulji Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Dongtan Sacred Heart Hospital
🇰🇷Hwaseong-si, Gyeonggi-do, Korea, Republic of
Baoji Central Hospital
🇨🇳Baoji, Shaanxi, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Anhui provincal Hospital
🇨🇳Hefei, Anhui, China
Lu'An People's Hospital
🇨🇳Lu'an, Anhui, China
Wuhan Third Hospital
🇨🇳Wuhan, Hubei, China
The People's Hospital of Xuancheng City
🇨🇳Xuancheng, Anhui, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Chongqing Emergency Medical Center
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chonggang General Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing Three Gorges Central Hospital
🇨🇳Chongqing, Chongqing, China
Fujian medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The 900th Hospital of Joint Logistics Support Force, PLA
🇨🇳Fuzhou, Fujian, China
Sun Yat-Sen Memorial Hospital of Zhongshan University
🇨🇳Guangzhou, Guangdong, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Hainan Medical College
🇨🇳Haikou, Hainan, 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
Wuhan Fourth hospital
🇨🇳Wuhan, Hubei, China
Renmin Hospital Of Wuhan University
🇨🇳Wuhan, Hubei, China
Huanggang Central Hospital
🇨🇳Huanggang, Hubei, China
Changsha Central Hospital
🇨🇳Changsha, Hunan, China
The Second 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
Wuxi people's Hospital
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Sir Run Run Hospital, Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical Hospital
🇨🇳Yinchuan, Ning Xia, China
The First People's Hospital of Yinchuan
🇨🇳Yinchuan, Ningxia, China
General Hospital of Northern Theater Command
🇨🇳Shenyang, Liaoning, China
Yan'an University Xianyang Hospital Co., Ltd
🇨🇳Xianyang, Shaanxi, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Qingdao Central Hospital
🇨🇳Qingdao, Shandong, China
Zaozhuang Municipal Hospital
🇨🇳Zaozhuang, Shandong, China
Xi'an Gaoxin Hospital Co., Ltd
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shaanxi, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, Shanxi, China
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Nankai University, Tianjin Union Medical Center
🇨🇳Tianjin, Tianjin, China
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, 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
Ruian People's Hospital
🇨🇳Rui'an, Zhejiang, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Taihe Hospital
🇨🇳Shiyan, Hubei, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
The Third Xiangya Hospital Of Central South University
🇨🇳Changsha, Hunan, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China
Wuxi Integrated Traditional Chinese and Western Medicine Hospital
🇨🇳Wuxi, Jiangsu, China
The First Affiliated Hospital With Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Shaanxi Provincial People' Hospital
🇨🇳Xi'an, Shaanxi, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Gangwon, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
The Second Affiliated hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China