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

Acute Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574362
• Other study ID #: BHV3000-310
• Secondary ID: C4951026
• Status: Completed
• Phase: Phase 3
• Start date: October 22, 2020
• Est. completion date: December 16, 2021

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1648
• Est. completion date: December 16, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
One 75mg orally disintegrating tablet
• Placebo
Matching placebo

Locations

Country	Name	City	State
China	Baoji Central Hospital	Baoji	Shaanxi
China	The first affiliated hospital of Baotou medical college of Inner Mongolia university of science and technology	Baotou	Inner Mongolia
China	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	1st Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
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	Heping Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Affiliated Hospital of Chifeng University	Chifeng	Inner Mongolia
China	Chonggang General Hospital	Chongqing	Chongqing
China	Chongqing Emergency Medical Center	Chongqing	Chongqing
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	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	Hainan General Hospital	Haikou	Hainan
China	The First Affiliated Hospital of Hainan Medical College	Haikou	Hainan
China	Anhui provincal Hospital	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Inner Mongolia People's Hospital	Hohhot	Inner Mongolia
China	Huanggang Central Hospital	Huanggang	Hubei
China	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	The Second Affiliated hospital of Kunming Medical University	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Lu'An People's Hospital	Lu'an	Anhui
China	Henan University of Science and Technology First Affiliated Hospital	Luoyang	Henan
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Sir Run Run Hospital, Nanjing Medical University	Nanjing	Jiangsu
China	The First Affiliated Hospital With Nanjing Medical University	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Qingdao Central Hospital	Qingdao	Shandong
China	Ruian People's Hospital	Rui'an	Zhejiang
China	Shanghai East Hospital	Shanghai	Shanghai
China	The Central Hospital of Shaoyang	Shaoyang	Hunan
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Taihe Hospital	Shiyan	Hubei
China	Zigong First People's Hospital	Sichuan	Igong
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Nankai University, Tianjin Union Medical Center	Tianjin	Tianjin
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Renmin Hospital Of Wuhan University	Wuhan	Hubei
China	Wuhan Fourth hospital	Wuhan	Hubei
China	Wuhan Third Hospital	Wuhan	Hubei
China	Wuxi Integrated Traditional Chinese and Western Medicine Hospital	Wuxi	Jiangsu
China	Wuxi people's Hospital	Wuxi	Jiangsu
China	Shaanxi Provincial People' Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shaanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xi'an Gaoxin Hospital Co., Ltd	Xi'an	Shaanxi
China	Yan'an University Xianyang Hospital Co., Ltd	Xianyang	Shaanxi
China	People's Hospital of Xinjiang Uygur Autonomous Region	Xinjiang	Wulumuqi
China	The Fifth Affiliated Hospital of Xinjiang Medical University	Xinjiang	Uramqi
China	The Second Affiliated Hospital of Xinjiang Medical University	Xinjiang	Wulumuqi
China	The People's Hospital of Xuancheng City	Xuancheng	Anhui
China	General Hospital of Ningxia Medical Hospital	Yinchuan	Ning Xia
China	The First People's Hospital of Yinchuan	Yinchuan	Ningxia
China	The First People's Hospital of Yueyang	Yueyang	Hunan
China	Zaozhuang Municipal Hospital	Zaozhuang	Shandong
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zhengzhou People's Hospital	Zhengzhou	Henan
China	The Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
China	Zhuzhou Central Hospital	Zhuzhou	Hunan
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Dongtan Sacred Heart Hospital	Hwaseong-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Ewha Womans University Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	BioShin Limited

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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