Clinical trial NCT04574362: Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
Official title: BHV3000-310: Phase 3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Migraine
Keywords: Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: BioShin Limited
First posted: 2020-10-05
Enrollment: 1648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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:

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.

Key Exclusion Criteria:

1. Subject with a history of HIV disease
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

Primary outcomes:
measure: Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: Percentage of Participants With Pain Relief at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Who Functioned Normally at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose
timeFrame: 24 hours post-dose
measure: Percentage of Participants Who Sustained Pain Freedom From 2 to 24 Hours Post-dose
timeFrame: 2 to 24 hours post-dose
measure: Percentage of Participants Who Sustained Pain Freedom From 2 to 48 Hours Post-dose
timeFrame: 2 to 48 hours post-dose
measure: Percentage of Participants Who Had Freedom From Pain at 15, 30, 45, 60 and 90 Minutes Post-dose
timeFrame: 15, 30, 45, 60 and 90 minutes post-dose
measure: Percentage of Participants Who Had Freedom From MBS at 15, 30, 45, 60 and 90 Minutes Post-dose
timeFrame: 15, 30, 45, 60 and 90 minutes post-dose
measure: Percentage of Participants With Pain Relapse
timeFrame: 2 Hours to 48 Hours Post-dose
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui provincal Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Lu'an
country: China
facility: Lu'An People's Hospital
state: Anhui
city: Xuancheng
country: China
facility: The People's Hospital of Xuancheng City
state: Anhui
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing Emergency Medical Center
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chonggang General Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: The 900th Hospital of Joint Logistics Support Force, PLA
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Zhongshan University
state: Guangdong
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical College
state: Hainan
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Luoyang
country: China
facility: Henan University of Science and Technology First Affiliated Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Huanggang
country: China
facility: Huanggang Central Hospital
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Fourth hospital
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital Of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan Third Hospital
state: Hubei
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital Of Central South University
state: Hunan
city: Shaoyang
country: China
facility: The Central Hospital of Shaoyang
state: Hunan
city: Yueyang
country: China
facility: The First People's Hospital of Yueyang
state: Hunan
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Sichuan
country: China
facility: Zigong First People's Hospital
state: Igong
city: Baotou
country: China
facility: The first affiliated hospital of Baotou medical college of Inner Mongolia university of science and technology
state: Inner Mongolia
city: Chifeng
country: China
facility: Affiliated Hospital of Chifeng University
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital With Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Sir Run Run Hospital, Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Integrated Traditional Chinese and Western Medicine Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi people's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: 1st Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical Hospital
state: Ning Xia
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Gaoxin Hospital Co., Ltd
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People' Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shaanxi
city: Xianyang
country: China
facility: Yan'an University Xianyang Hospital Co., Ltd
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Nankai University, Tianjin Union Medical Center
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
city: Xinjiang
country: China
facility: The Fifth Affiliated Hospital of Xinjiang Medical University
state: Uramqi
city: Xinjiang
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
state: Wulumuqi
city: Xinjiang
country: China
facility: The Second Affiliated Hospital of Xinjiang Medical University
state: Wulumuqi
city: Kunming
country: China
facility: The Second Affiliated hospital of Kunming Medical University
state: Yunnan
city: Rui'an
country: China
facility: Ruian People's Hospital
state: Zhejiang
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Hwaseong-si
country: Korea, Republic of
facility: Dongtan Sacred Heart Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: