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Acute MigrainePhase 3NCT04574362

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

A Phase 3 study testing Rimegepant in people with Acute Migraine, run by Pfizer at 90 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Migraine
What is being tested?
Rimegepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,648 participants
Where
90 sitesin 2 countries
Study dates
22 Oct 2020to 16 Dec 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

90 sites in 2 countries.

90 sites in 2 countries

China77 sites

  • Baoji Central Hospital

    Baoji, Shaanxi, 721008

  • The first affiliated hospital of Baotou medical college of Inner Mongolia university of science and technology

    Baotou, Inner Mongolia, 014010

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100039

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233030

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061017

  • 1st Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Changsha Central Hospital

    Changsha, Hunan, 410004

  • The Second Xiangya Hospital Of Central South University

    Changsha, Hunan, 410011

  • The Third Xiangya Hospital Of Central South University

    Changsha, Hunan, 410013

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046099

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Affiliated Hospital of Chifeng University

    Chifeng, Inner Mongolia, 024050

  • Chongqing Emergency Medical Center

    Chongqing, Chongqing Municipality, 400014

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

  • Chonggang General Hospital

    Chongqing, Chongqing Municipality, 400080

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404199

  • Fujian medical University Union Hospital

    Fuzhou, Fujian, 350001

  • The 900th Hospital of Joint Logistics Support Force, PLA

    Fuzhou, Fujian, 350025

  • Sun Yat-Sen Memorial Hospital of Zhongshan University

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital of Hainan Medical College

    Haikou, Hainan, 570102

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Anhui provincal Hospital

    Hefei, Anhui, 230001

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 010017

  • Huanggang Central Hospital

    Huanggang, Hubei, 438099

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong, 250013

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434020

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272029

  • The Second Affiliated hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222023

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252004

  • Lu'An People's Hospital

    Lu'an, Anhui, 237011

  • Henan University of Science and Technology First Affiliated Hospital

    Luoyang, Henan, 471003

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210028

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital With Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Sir Run Run Hospital, Nanjing Medical University

    Nanjing, Jiangsu, 211112

  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

  • Ruian People's Hospital

    Rui’an, Zhejiang, 325299

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

  • The Central Hospital of Shaoyang

    Shaoyang, Hunan, 422099

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110015

  • Taihe Hospital

    Shiyan, Hubei, 442000

  • Zigong First People's Hospital

    Sichuan, Igong, 643000

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Nankai University, Tianjin Union Medical Center

    Tianjin, Tianjin Municipality, 300121

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300222

  • Wuhan Fourth hospital

    Wuhan, Hubei, 430034

  • Renmin Hospital Of Wuhan University

    Wuhan, Hubei, 430060

  • Wuhan Third Hospital

    Wuhan, Hubei, 430073

  • Wuxi Integrated Traditional Chinese and Western Medicine Hospital

    Wuxi, Jiangsu, 214000

  • Wuxi people's Hospital

    Wuxi, Jiangsu, 214043

  • Xi'an Gaoxin Hospital Co., Ltd

    Xi'an, Shaanxi, 710000

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

  • Shaanxi Provincial People' Hospital

    Xi'an, Shaanxi, 710068

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi, 710077

  • Yan'an University Xianyang Hospital Co., Ltd

    Xianyang, Shaanxi, 712000

  • The Fifth Affiliated Hospital of Xinjiang Medical University

    Xinjiang, Uramqi, 830011

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Xinjiang, Wulumuqi, 830001

  • The Second Affiliated Hospital of Xinjiang Medical University

    Xinjiang, Wulumuqi, 830018

  • The People's Hospital of Xuancheng City

    Xuancheng, Anhui, 242299

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia, 750001

  • General Hospital of Ningxia Medical Hospital

    Yinchuan, Ningxia, 750003

  • The First People's Hospital of Yueyang

    Yueyang, Hunan, 414000

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong, 277102

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • Zhengzhou People's Hospital

    Zhengzhou, Henan, 450014

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412007

Other trials in China

South Korea13 sites

  • Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwon-do, 24253

  • Chungnam National University Hospital

    Daejeon, 35015

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggi-do, 10380

  • Dongtan Sacred Heart Hospital

    Hwaseong-si, Gyeonggi-do, 18450

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Nowon Eulji Medical Center

    Seoul, 01830

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital

    Seoul, 03722

  • Kangdong Sacred Heart Hospital

    Seoul, 05355

  • Samsung Medical Center

    Seoul, 06351

  • Ewha Womans University Medical Center

    Seoul, 07804

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

About this study

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

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

Read the detailed description

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

Conditions
Acute Migraine
Being tested
Rimegepant, Placebo
Keywords
Migraine
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RimegepantDrug

    One 75mg orally disintegrating tablet

  • PlaceboDrug

    Matching placebo

Study groups in NCT04574362
Study groupRoleWhat they receive
Rimegepant 75mgActive comparatorOne 75mg oral disintegration tablet
Receives: Drug: Rimegepant
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 hours post-dose

  2. 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.

    Measured: 2 hours post-dose

Secondary outcomes (8)

  1. 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.

    Measured: 2 hours post-dose

  2. 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.

    Measured: 2 hours post-dose

  3. 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.

    Measured: 24 hours post-dose

  4. 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.

    Measured: 2 to 24 hours post-dose

  5. 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.

    Measured: 2 to 48 hours post-dose

  6. 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.

    Measured: 15, 30, 45, 60 and 90 minutes post-dose

  7. 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.

    Measured: 15, 30, 45, 60 and 90 minutes post-dose

  8. 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.

    Measured: 2 Hours to 48 Hours Post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start22 Oct 2020
  3. Primary completion24 Nov 2021
  4. Study completion16 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04574362
Sponsor's protocol ID
BHV3000-310
Other IDs
C4951026
Status last verified
Mar 2023
First submitted
27 Sep 2020
Last updated
14 Dec 2023
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yu S, Guo A, Wang Z, Liu J, Tan G, Yang Q, Zhang M, Yibulaiyin H, Chen H, Zhang Y, Croop R, Sun Y, Liu Y, Zhao Q, Lu Z. Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial. J Headache Pain. 2024 Apr 16;25(1):57. doi: 10.1186/s10194-024-01731-4.

    PubMed 38627638

  • Yu S, Kim BK, Guo A, Kim MH, Zhang M, Wang Z, Liu J, Moon HS, Tan G, Yang Q, McGrath D, Hanna M, Stock DA, Gao Y, Croop R, Lu Z. Safety and efficacy of rimegepant orally disintegrating tablet for the acute treatment of migraine in China and South Korea: a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2023 Jun;22(6):476-484. doi: 10.1016/S1474-4422(23)00126-6.

    PubMed 37210098

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rimegepant in people with Acute Migraine, run by Pfizer at 90 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose (time frame: 2 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04574362, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.

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