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

Sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04574362
Collaborator
BioShin Limited (Other)
1,648
Enrollment
90
Locations
2
Arms
13.8
Actual Duration (Months)
18.3
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
1648 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 22, 2020
Actual Primary Completion Date :
Nov 24, 2021
Actual Study Completion Date :
Dec 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rimegepant 75mg

One 75mg oral disintegration tablet

Drug: Rimegepant
One 75mg orally disintegrating tablet
Placebo Comparator: Placebo

Matching placebo

Drug: Placebo
Matching placebo

Outcome Measures

Primary Outcome Measures

  1. To compare rimegepant to placebo on pain freedom. [2 hours post-dose]

    Pain freedom will be measured by the number of subjects that report no pain. Pain freedom is measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).

  2. To compare rimegepant to placebo on freedom from Most Bothersome Symptom [2 hours post-dose]

    Freedom from Most Bothersome Symptom will be measured using the number of subjects that report the absence of their MBS (nausea, phonophobia or photophobia) and will measured as (0=absent, 1=present).

Secondary Outcome Measures

  1. To compare rimegepant to placebo on pain relief [2 hours post-dose]

    Pain relief will be measured using the percentage of subjects with a pain intensity of none or mild.

  2. To compare rimegepant to placebo on the ability to function normally at 2 hours post-dose as reported on the Functional Disability scale [2 hours post-dose]

    The ability to function normally will be measured using the number of subjects that self-report as "normal" on the Functional Disability scale

  3. To compare rimegepant to placebo on the Use of Rescue Medications [24 hours post-dose]

    The use of rescue medications will be measured using the number of subjects that take rescue medication.

  4. To compare rimegepant to placebo on sustained pain freedom [2 to 24 hours post-dose]

    Pain freedom will be measured using the number of subjects that do not experience any headache pain.

  5. To compare rimegepant to placebo on sustained pain freedom [2 to 48 hours post-dose]

    Pain freedom will be measured using the number of subjects that do not experience any headache pain.

  6. To compare rimegepant to placebo on pain freedom [15, 30, 45, 60 and 90 minutes post-dose]

    Pain freedom will be measured using the number of subjects that report a pain level of moderate or severe just before taking study medication and then report a pain level of none at the timepoint of interest.

  7. To compare rimegepant to placebo on freedom from Most Bothersome Symptom [15, 30, 45, 60 and 90 minutes post-dose]

    Pain freedom will be measured using the number of subjects that report the absence of their Most Bothersome Symptom.

  8. To compare rimegepant to placebo for the incidence of pain relapse [2 to 48 hours post-dose]

    Pain relapse will be measured using the number of subjects that are pain free at 2 hours post-dose and then have a migraine of any pain severity (response of: 2 or 3 on the 4 point scale) within 48 hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233030
2 Anhui provincal Hospital Hefei Anhui China 230001
3 The Second Hospital of Anhui Medical University Hefei Anhui China 230601
4 Lu'An People's Hospital Lu'an Anhui China 237011
5 The People's Hospital of Xuancheng City Xuancheng Anhui China 242299
6 Chinese PLA General Hospital Beijing Beijing China 100039
7 Peking University People's Hospital Beijing Beijing China 100044
8 Beijing Friendship Hospital,Capital Medical University Beijing Beijing China 100050
9 Chongqing Emergency Medical Center Chongqing Chongqing China 400014
10 The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400042
11 Chonggang General Hospital Chongqing Chongqing China 400080
12 Chongqing Three Gorges Central Hospital Chongqing Chongqing China 404199
13 Fujian medical University Union Hospital Fuzhou Fujian China 350001
14 The 900th Hospital of Joint Logistics Support Force, PLA Fuzhou Fujian China 350025
15 Lanzhou University Second Hospital Lanzhou Gansu China 730030
16 Sun Yat-Sen Memorial Hospital of Zhongshan University Guangzhou Guangdong China 510120
17 The First Affiliated Hospital of Hainan Medical College Haikou Hainan China 570102
18 Hainan General Hospital Haikou Hainan China 570311
19 Cangzhou Central Hospital Cangzhou Hebei China 061017
20 Henan University of Science and Technology First Affiliated Hospital Luoyang Henan China 471003
21 Henan Provincial People's Hospital Zhengzhou Henan China 450003
22 Zhengzhou People's Hospital Zhengzhou Henan China 450014
23 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
24 Huanggang Central Hospital Huanggang Hubei China 438099
25 Jingzhou Central Hospital Jingzhou Hubei China 434020
26 Taihe Hospital Shiyan Hubei China 442000
27 Wuhan Fourth hospital Wuhan Hubei China 430034
28 Renmin Hospital Of Wuhan University Wuhan Hubei China 430060
29 Wuhan Third Hospital Wuhan Hubei China 430073
30 Changsha Central Hospital Changsha Hunan China 410004
31 The Second Xiangya Hospital Of Central South University Changsha Hunan China 410011
32 The Third Xiangya Hospital Of Central South University Changsha Hunan China 410013
33 The Central Hospital of Shaoyang Shaoyang Hunan China 422099
34 The First People's Hospital of Yueyang Yueyang Hunan China 414000
35 Zhuzhou Central Hospital Zhuzhou Hunan China 412007
36 Zigong First People's Hospital Sichuan Igong China 643000
37 The first affiliated hospital of Baotou medical college of Inner Mongolia university of science and technology Baotou Inner Mongolia China 014010
38 Affiliated Hospital of Chifeng University Chifeng Inner Mongolia China 024050
39 Inner Mongolia People's Hospital Hohhot Inner Mongolia China 010017
40 The Second People's Hospital of Lianyungang Lianyungang Jiangsu China 222023
41 Nanjing Drum Tower Hospital Nanjing Jiangsu China 210008
42 Zhongda Hospital Southeast University Nanjing Jiangsu China 210009
43 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210028
44 Nanjing Brain Hospital Nanjing Jiangsu China 210029
45 The First Affiliated Hospital With Nanjing Medical University Nanjing Jiangsu China 210029
46 Sir Run Run Hospital, Nanjing Medical University Nanjing Jiangsu China 211112
47 Wuxi Integrated Traditional Chinese and Western Medicine Hospital Wuxi Jiangsu China 214000
48 Wuxi people's Hospital Wuxi Jiangsu China 214043
49 The Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 212001
50 1st Hospital of Jilin University Changchun Jilin China 130021
51 The Second Hospital of Jilin University Changchun Jilin China 130041
52 General Hospital of Northern Theater Command Shenyang Liaoning China 110015
53 General Hospital of Ningxia Medical Hospital Yinchuan Ning Xia China 750003
54 The First People's Hospital of Yinchuan Yinchuan Ningxia China 750001
55 Baoji Central Hospital Baoji Shaanxi China 721008
56 Xi'an Gaoxin Hospital Co., Ltd Xi'an Shaanxi China 710000
57 The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710004
58 Shaanxi Provincial People' Hospital Xi'an Shaanxi China 710068
59 The First Affiliated Hospital of Xi'an Medical University Xi'an Shaanxi China 710077
60 Yan'an University Xianyang Hospital Co., Ltd Xianyang Shaanxi China 712000
61 Shandong Provincial Qianfoshan Hospital Jinan Shandong China 250013
62 Affiliated Hospital of Jining Medical University Jining Shandong China 272029
63 Liaocheng People's Hospital Liaocheng Shandong China 252004
64 Qingdao Central Hospital Qingdao Shandong China 266042
65 Zaozhuang Municipal Hospital Zaozhuang Shandong China 277102
66 Shanghai East Hospital Shanghai Shanghai China 200120
67 Heping Hospital Affiliated to Changzhi Medical College Changzhi Shanxi China 046099
68 The Second Hospital of Shanxi Medical University Taiyuan Shanxi China 030000
69 First Hospital of Shanxi Medical University Taiyuan Shanxi China 030001
70 West China Hospital of Sichuan University Chengdu Sichuan China 610041
71 Nankai University, Tianjin Union Medical Center Tianjin Tianjin China 300121
72 Tianjin Huanhu Hospital Tianjin Tianjin China 300222
73 The Fifth Affiliated Hospital of Xinjiang Medical University Xinjiang Uramqi China 830011
74 People's Hospital of Xinjiang Uygur Autonomous Region Xinjiang Wulumuqi China 830001
75 The Second Affiliated Hospital of Xinjiang Medical University Xinjiang Wulumuqi China 830018
76 The Second Affiliated hospital of Kunming Medical University Kunming Yunnan China 650101
77 Ruian People's Hospital Rui'an Zhejiang China 325299
78 Chuncheon Sacred Heart Hospital Chuncheon Gangwon Korea, Republic of 24253
79 Inje University Ilsan Paik Hospital Goyang-si Gyeonggi-do Korea, Republic of 10380
80 Dongtan Sacred Heart Hospital Hwaseong-si Gyeonggi-do Korea, Republic of 18450
81 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620
82 Chungnam National University Hospital Daejeon Korea, Republic of 35015
83 Nowon Eulji Medical Center Seoul Korea, Republic of 01830
84 Seoul National University Hospital Seoul Korea, Republic of 03080
85 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
86 Severance Hospital Seoul Korea, Republic of 03722
87 Kangdong Sacred Heart Hospital Seoul Korea, Republic of 05355
88 Samsung Medical Center Seoul Korea, Republic of 06351
89 Ewha Womans University Medical Center Seoul Korea, Republic of 07804
90 Korea University Guro Hospital Seoul Korea, Republic of 08308

Sponsors and Collaborators

  • Biohaven Pharmaceuticals, Inc.
  • BioShin Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT04574362
Other Study ID Numbers:
  • BHV3000-310
First Posted:
Oct 5, 2020
Last Update Posted:
Dec 22, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Biohaven Pharmaceuticals, Inc.
Migraine
Additional relevant MeSH terms:
Migraine Disorders

Study Results

No Results Posted as of Dec 22, 2021