Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

BHV3000-310: Phase 3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

This trial is to determine whether BHV3000 (rimegepant) 75mg is safe and effictive as a treatment for acute migraine in Chinese and Korean patients

Study Overview

• Status: Completed
• Conditions: Acute Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Rimegepant

Detailed Description

Biohaven Pharmaceuticals, Inc. is the agent for BioShin Limited, the sponsor of the studies in China and Korea.

• Study Type: Interventional
• Enrollment (Actual): 1648
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233030
      • The First Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China, 230601
      • The Second Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230001
      • Anhui Provincal Hospital
    • Lu'an, Anhui, China, 237011
      • Lu'an People's Hospital
    • Xuancheng, Anhui, China, 242299
      • The People's Hospital Of Xuancheng City
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital,Capital Medical University
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing, China, 100039
      • Chinese PLA General Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 404199
      • Chongqing Three Gorges Central Hospital
    • Chongqing, Chongqing, China, 400014
      • Chongqing Emergency Medical Center
    • Chongqing, Chongqing, China, 400080
      • Chonggang General Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350025
      • The 900th Hospital of Joint Logistics Support Force, PLA
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hospital of Zhongshan University
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
    • Haikou, Hainan, China, 570102
      • The First Affiliated Hospital Of Hainan Medical College
  • Hebei
    • Cangzhou, Hebei, China, 061017
      • Cangzhou Central Hospital
  • Henan
    • Luoyang, Henan, China, 471003
      • Henan University of Science and Technology First Affiliated Hospital
    • Zhengzhou, Henan, China, 450052
      • the First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China, 450014
      • Zhengzhou People's Hospital
  • Hubei
    • Huanggang, Hubei, China, 438099
      • Huanggang Central Hospital
    • Jingzhou, Hubei, China, 434020
      • Jingzhou Central Hospital
    • Shiyan, Hubei, China, 442000
      • Taihe Hospital
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430034
      • Wuhan Fourth Hospital
    • Wuhan, Hubei, China, 430073
      • Wuhan Third Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410004
      • Changsha Central Hospital
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
    • Shaoyang, Hunan, China, 422099
      • The Central Hospital of Shaoyang
    • Yueyang, Hunan, China, 414000
      • The First People's Hospital of Yueyang
    • Zhuzhou, Hunan, China, 412007
      • ZhuZhou Central Hospital
  • Igong
    • Sichuan, Igong, China, 643000
      • Zigong First People's Hospital
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology
    • Chifeng, Inner Mongolia, China, 024050
      • Affiliated Hospital of Chifeng University
    • Hohhot, Inner Mongolia, China, 010017
      • Inner Mongolia People's Hospital
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222023
      • The Second People's Hospital of Lianyungang
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital with Nanjing Medical University
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Brain Hospital
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China, 210028
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 211112
      • Sir Run Run Hospital, Nanjing Medical University
    • Wuxi, Jiangsu, China, 214000
      • Wuxi Integrated Traditional Chinese and Western Medicine Hospital
    • Wuxi, Jiangsu, China, 214043
      • Wuxi People's Hospital
    • Zhenjiang, Jiangsu, China, 212001
      • The Affiliated Hospital of Jiangsu University
  • Jilin
    • Changchun, Jilin, China, 130021
      • 1st Hospital of Jilin University
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110015
      • General Hospital of Northern Theater Command
  • Ning Xia
    • Yinchuan, Ning Xia, China, 750003
      • General Hospital of Ningxia Medical Hospital
  • Ningxia
    • Yinchuan, Ningxia, China, 750001
      • The First People's Hospital of Yinchuan
  • Shaanxi
    • Baoji, Shaanxi, China, 721008
      • Baoji Central Hospital
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China, 710000
      • Xi'an Gaoxin Hospital Co., Ltd
    • Xi'an, Shaanxi, China, 710068
      • Shaanxi Provincial People' Hospital
    • Xi'an, Shaanxi, China, 710077
      • The First Affiliated Hospital of Xi'an Medical University
    • Xianyang, Shaanxi, China, 712000
      • Yan'an University Xianyang Hospital Co., Ltd
  • Shandong
    • Jinan, Shandong, China, 250013
      • Shandong Provincial Qianfoshan Hospital
    • Jining, Shandong, China, 272029
      • Affiliated Hospital of Jining Medical University
    • Liaocheng, Shandong, China, 252004
      • Liaocheng People's Hospital
    • Qingdao, Shandong, China, 266042
      • Qingdao Central Hospital
    • Zaozhuang, Shandong, China, 277102
      • Zaozhuang Municipal Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital
  • Shanxi
    • Changzhi, Shanxi, China, 046099
      • Heping Hospital Affiliated to Changzhi Medical College
    • Taiyuan, Shanxi, China, 030001
      • First Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 030000
      • The Second Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300121
      • Nankai University, Tianjin Union Medical Center
    • Tianjin, Tianjin, China, 300222
      • Tianjin Huanhu Hospital
  • Uramqi
    • Xinjiang, Uramqi, China, 830011
      • The Fifth Affiliated Hospital of Xinjiang Medical University
  • Wulumuqi
    • Xinjiang, Wulumuqi, China, 830001
      • People's Hospital of Xinjiang Uygur Autonomous Region
    • Xinjiang, Wulumuqi, China, 830018
      • The Second Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650101
      • The Second Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Rui'an, Zhejiang, China, 325299
      • Ruian People's Hospital
• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 05355
    • Kangdong Sacred Heart Hospital
  • Seoul, Korea, Republic of, 01830
    • Nowon Eulji Medical Center
  • Seoul, Korea, Republic of, 07804
    • Ewha Womans University Medical Center
  • Gangwon
    • Chuncheon, Gangwon, Korea, Republic of, 24253
      • Chuncheon Sacred Heart Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
      • Inje University Ilsan Paik Hospital
    • Hwaseong-si, Gyeonggi-do, Korea, Republic of, 18450
      • Dongtan Sacred Heart Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Matching placebo
Active Comparator: Rimegepant 75mg; One 75mg oral disintegration tablet	Drug: Rimegepant; One 75mg orally disintegrating tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Had Freedom From Pain at 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.	2 hours post-dose
Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 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.	2 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Pain Relief at 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.	2 hours post-dose
Percentage of Participants Who Functioned Normally at 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.	2 hours post-dose
Percentage of Participants Who Used Rescue Medication Within 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.	24 hours post-dose
Percentage of Participants Who Sustained Pain Freedom From 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.	2 to 24 hours post-dose
Percentage of Participants Who Sustained Pain Freedom From 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.	2 to 48 hours post-dose
Percentage of Participants Who Had Freedom From Pain at 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.	15, 30, 45, 60 and 90 minutes post-dose
Percentage of Participants Who Had Freedom From MBS at 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.	15, 30, 45, 60 and 90 minutes post-dose
Percentage of Participants With Pain Relapse	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.	2 Hours to 48 Hours Post-dose

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: BioShin Limited
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): December 16, 2021

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: BHV3000-310; C4951026 (Other Identifier: Alias Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No