AzTrials
AzTrials

Pediatric MigrainePhase 3NCT04649242

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

A Phase 3 study testing Rimegepant/BHV3000 in people with Pediatric Migraine, run by Pfizer at 246 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Pediatric Migraine
What is being tested?
Rimegepant/BHV3000
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,100 participants
Where
246 sitesin 9 countries
Study dates
15 Jan 2021to 9 Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
  • History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours.
  • Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.
  • Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.
  • Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
  • Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
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  • Verbally distinguish between migraine and other types of headaches.
  • Participants must have a weight > 40 kg at the Screening Visit.
  • Adequate venous access for blood sampling.
  • Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).

Who cannot join

  • History of cluster headache or hemiplegic migraine headache.
  • Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
  • Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
  • History of suicidal behavior or major psychiatric disorder.
  • Current diagnosis or history of substance abuse; positive drug test at Screening.
  • History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
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  • Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
  • Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
  • Current diagnosis of viral hepatitis or a history of liver disease.
  • Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Trial locations and contacts

246 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Pfizer Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

246 sites in 9 countries

United States169 sites, 72 recruiting

  • Akron Children's Hospital

    Akron, Ohio, 44308

    Active, not recruiting

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

    Recruiting

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

    Recruiting

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

    Recruiting

  • Topaz Clinical Research, Inc.

    Apopka, Florida, 32703

    Active, not recruiting

  • Children's Healthcare of Atlanta, Inc.

    Atlanta, Georgia, 30329

    Active, not recruiting

  • Childrens Healthcare of Atlanta

    Atlanta, Georgia, 30329

    Active, not recruiting

  • Rare Disease Research, LLC

    Atlanta, Georgia, 30329

    Active, not recruiting

  • Children's Hospital Colorado- lnvestigational Drug Services

    Aurora, Colorado, 80045

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Recruiting

  • Dell Children's Medical Center

    Austin, Texas, 78723

    Recruiting

  • Child Neurology Consultants of Austin - South Austin

    Austin, Texas, 78749

    Active, not recruiting

  • Child Neurology Consultants of Austin - Central Austin

    Austin, Texas, 78757

    Active, not recruiting

  • BioBehavioral Research of Austin

    Austin, Texas, 78759

    Active, not recruiting

  • Houston Clinical Trials, LLC

    Bellaire, Texas, 77401

    Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

    Recruiting

  • Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama

    Birmingham, Alabama, 35244

    Active, not recruiting

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

    Active, not recruiting

  • Pivotal Clinical Research & Associates, LLC

    Brunswick, Georgia, 31520

    Active, not recruiting

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

    Active, not recruiting

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211

    Active, not recruiting

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28277

    Recruiting

  • Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

    Charlottesville, Virginia, 22902

    Recruiting

  • Pediatric Research of Charlottesville, LLC (Regulatory Only)

    Charlottesville, Virginia, 22902

    Recruiting

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902

    Recruiting

  • Chicago Headache Center & Research Institute

    Chicago, Illinois, 60657

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Recruiting

  • Velocity Clinical Research

    Cincinnati, Ohio, 45242

    Active, not recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Colorado Springs Neurological Associates, PC

    Colorado Springs, Colorado, 80907

    Active, not recruiting

  • Colorado Springs Neurological Associates, PC

    Colorado Springs, Colorado, 80919

    Active, not recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Active, not recruiting

  • Wellnow Urgent Care and Research

    Columbus, Ohio, 43228

    Active, not recruiting

  • True North Neurology

    Commack, New York, 11725

    Recruiting

  • Adult & Child Neurology Medical Associates

    Costa Mesa, California, 92627

    Recruiting

  • CT Clinical Research

    Cromwell, Connecticut, 06416

    Recruiting

  • ProScience Research Group

    Culver City, California, 90230

    Active, not recruiting

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida, 33157

    Terminated

  • Infinite Research Group, LLC

    Dallas, Texas, 75201

    Active, not recruiting

  • Children's Medical Center, Dallas

    Dallas, Texas, 75235

    Active, not recruiting

  • Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)

    Dallas, Texas, 75235

    Active, not recruiting

  • Cedar Health Research

    Dallas, Texas, 75251

    Active, not recruiting

  • FutureSearch Trials of Dallas, LLC

    Dallas, Texas, 75251

    Recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Active, not recruiting

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030

    Recruiting

  • DeLand Clinical Research Unit

    DeLand, Florida, 32720

    Terminated

  • Velocity Clinical Research-Providence

    East Greenwich, Rhode Island, 02818

    Recruiting

  • ANESC Research

    El Paso, Texas, 79912

    Recruiting

  • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

    Everett, Washington, 98201

    Active, not recruiting

  • Precise Research Centers

    Flowood, Mississippi, 39232

    Recruiting

  • Memorial Health Services

    Fountain Valley, California, 92708

    Recruiting

  • Neuro-Pain Research Center

    Fresno, California, 93710

    Recruiting

  • North Texas Institute of Neurology and Headache

    Frisco, Texas, 75034

    Active, not recruiting

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

    Active, not recruiting

  • Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group

    Grand Rapids, Michigan, 49503

    Recruiting

  • Corewell Health, Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Recruiting

  • Velocity Clinical Research, Grants Pass

    Grants Pass, Oregon, 97527

    Active, not recruiting

  • Boeson Research

    Great Falls, Montana, 59405

    Active, not recruiting

  • Northwell Health IRB

    Great Neck, New York, 11021

    Recruiting

  • Headache Wellness Center, PC

    Greensboro, North Carolina, 27405

    Active, not recruiting

  • Premier Neurology, PC

    Greenville, South Carolina, 29605

    Active, not recruiting

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

    Active, not recruiting

  • Velocity Clinical Research - Greenville

    Greenville, South Carolina, 29615

    Active, not recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Active, not recruiting

  • UTHealth Houston

    Houston, Texas, 77030

    Recruiting

  • Pain and Headache Centers of Texas

    Houston, Texas, 77054

    Recruiting

  • SCLA Management

    Houston, Texas, 77077

    Recruiting

  • Houston Clinical Research,LLC.

    Houston, Texas, 77081

    Active, not recruiting

  • NeuroCare Plus

    Houston, Texas, 77094

    Recruiting

  • Wellnow Urgent Care and Research

    Kalamazoo, Michigan, 49048

    Active, not recruiting

  • Boeson Research

    Kalispell, Montana, 59901

    Active, not recruiting

  • Heart & Hands Midwifery

    Kalispell, Montana, 59901

    Active, not recruiting

  • Clinical Associates Midwest, LLC

    Kansas City, Kansas, 66214

    Recruiting

  • Clinical Investigation Specialists, Inc

    Kenosha, Wisconsin, 53144

    Recruiting

  • Holston Medical Group.

    Kingsport, Tennessee, 37660

    Active, not recruiting

  • Holston Medical Group

    Kingsport, Tennessee, 37660

    Active, not recruiting

  • Altman Clinical and Translational Research Institute, University of California San Diego

    La Jolla, California, 92037

    Recruiting

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 32055

    Active, not recruiting

  • Northwell Health Division of Pediatric Neurology Outpatient EEG Lab

    Lake Success, New York, 11042

    Recruiting

  • Northwell Health/ Division of Pediatric Neurology

    Lake Success, New York, 11042

    Recruiting

  • Watson Clinic Center for Research, Inc.

    Lakeland, Florida, 33805

    Terminated

  • Watson Clinic LLP

    Lakeland, Florida, 33805

    Terminated

  • Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"

    Lexington, Kentucky, 40504

    Active, not recruiting

  • UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"

    Lexington, Kentucky, 40536

    Active, not recruiting

  • University of Kentucky Hospital

    Lexington, Kentucky, 40536

    Active, not recruiting

  • Alivation Research, LLC.

    Lincoln, Nebraska, 68526

    Terminated

  • Adult & Child Neurology Medical Associates

    Long Beach, California, 90806

    Recruiting

  • Miller Children's & Women's Hospital Long Beach

    Long Beach, California, 90806

    Recruiting

  • National Research Institute

    Los Angeles, California, 90057

    Active, not recruiting

  • University Hospital

    Madison, Wisconsin, 53792

    Recruiting

  • Le Bonheur Children's Hospital - Outpatient Building

    Memphis, Tennessee, 38103

    Active, not recruiting

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103

    Active, not recruiting

  • Le Bonheur Childrens Hospital - Childrens Foundation Research Institute

    Memphis, Tennessee, 38103

    Active, not recruiting

  • AppleMed Research Group, LLC

    Miami, Florida, 33126

    Active, not recruiting

  • Medical Research Center of Miami II, Inc

    Miami, Florida, 33134

    Active, not recruiting

  • South Florida Research Phase I-IV, Inc

    Miami, Florida, 33166

    Recruiting

  • Brainstorm Research

    Miami, Florida, 33176

    Active, not recruiting

  • NYU Langone Hospital-Long Island, Clinical Research Center

    Mineola, New York, 11501

    Active, not recruiting

  • NYU Langone Hospital-Long Island, Pediatric Neurology

    Mineola, New York, 11501

    Active, not recruiting

  • Blue Moose Pediatrics

    Missoula, Montana, 59804

    Active, not recruiting

  • Boeson Research Laboratory

    Missoula, Montana, 59804

    Active, not recruiting

  • Boeson Research

    Missoula, Montana, 59804

    Active, not recruiting

  • AMR-Baber Research Inc

    Naperville, Illinois, 60563

    Recruiting

  • Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office

    Naples, Florida, 34102

    Active, not recruiting

  • Aqualane Clinical Research

    Naples, Florida, 34105

    Recruiting

  • Access Clinical Trials, Inc.

    Nashville, Tennessee, 37203

    Active, not recruiting

  • HMH Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Recruiting

  • HOPE Tower at Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

    Active, not recruiting

  • New York Neurology Associates

    New York, New York, 10003

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

    Recruiting

  • Mount Sinai Hospital - Pharmacy Department

    New York, New York, 10029

    Active, not recruiting

  • Columbia University Medical Center Research Pharmacy

    New York, New York, 10032

    Active, not recruiting

  • Columbia University Pediatric Neuromuscular Center

    New York, New York, 10032

    Active, not recruiting

  • Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit

    New York, New York, 10032

    Active, not recruiting

  • The Neurological Institute of New York

    New York, New York, 10032

    Active, not recruiting

  • The Trustees of Columbia University and The New York and Presbyterian Hospital

    New York, New York, 10032

    Active, not recruiting

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507

    Recruiting

  • CHKD Health Center

    Norfolk, Virginia, 23510

    Recruiting

  • Neuro-Behavioral Clinical Research, Inc.

    North Canton, Ohio, 44720

    Active, not recruiting

  • Velocity Clinical Research - North Hollywood

    North Hollywood, California, 91606

    Active, not recruiting

  • IPS Research Company

    Oklahoma City, Oklahoma, 73106

    Active, not recruiting

  • Children's Hospital & Medical Center

    Omaha, Nebraska, 68114

    Recruiting

  • Children's Hospital of Orange County - Inpatient Pharmacy

    Orange, California, 92868

    Not yet recruiting

  • Children's Hospital of Orange County - Neuroscience Center

    Orange, California, 92868

    Not yet recruiting

  • Children's Hospital of Orange County

    Orange, California, 92868

    Not yet recruiting

  • Coastal Clinical Research Specialists

    Orange Park, Florida, 32073

    Active, not recruiting

  • Clinical Associates of Orlando, LLC

    Orlando, Florida, 32819

    Recruiting

  • College Park Family Care Center Physicians Group- Neurology Research Dept.

    Overland Park, Kansas, 66212

    Active, not recruiting

  • Sharlin Health Neuroscience Research Center

    Ozark, Missouri, 65721

    Active, not recruiting

  • Bioresearch Institute

    Pembroke Pines, Florida, 33026

    Terminated

  • Clario

    Philadelphia, Pennsylvania, 19103

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Active, not recruiting

  • AIM Trials, LLC

    Plano, Texas, 75093

    Active, not recruiting

  • The Neurology Group

    Pomona, California, 91767

    Recruiting

  • North Suffolk Neurology P.C

    Port Jefferson Station, New York, 11776

    Active, not recruiting

  • Providence Neuroscience Institute - Research Coordinator's Office

    Portland, Oregon, 97225

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    Recruiting

  • National Clinical Research, Inc.

    Richmond, Virginia, 23294

    Active, not recruiting

  • Brackenridge Outpatient Research Pharmacy

    Rochester, Minnesota, 55905

    Recruiting

  • Clinical Research Trials Unit

    Rochester, Minnesota, 55905

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

    Terminated

  • Beaumont Hospital Royal Oak Campus

    Royal Oak, Michigan, 48073

    Active, not recruiting

  • University of California, Davis Midtown Clinic

    Sacramento, California, 95816

    Active, not recruiting

  • UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy

    Sacramento, California, 95817

    Active, not recruiting

  • University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)

    Sacramento, California, 95817

    Active, not recruiting

  • JBR Clinical Research

    Salt Lake City, Utah, 84107

    Recruiting

  • Wasatch Clinical Research , LLC(Administrative Location)

    Salt Lake City, Utah, 84107

    Recruiting

  • Velocity Clinical Research, San Bernardino

    San Bernardino, California, 92408

    Active, not recruiting

  • Perseverance Research Center, LLC

    Scottsdale, Arizona, 85253

    Recruiting

  • Seattle Children's Hospital Investigational Drug Services

    Seattle, Washington, 98105

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Recruiting

  • Neurology and Headache Center, Inc.

    Shreveport, Louisiana, 71105

    Active, not recruiting

  • Velocity Clinical Research, Sioux City

    Sioux City, Iowa, 51106

    Recruiting

  • Clinvest Research, LLC

    Springfield, Missouri, 65810

    Active, not recruiting

  • Ki Health Partners, LLc, dba New England Institute for Clinical Research

    Stamford, Connecticut, 06905

    Recruiting

  • Forcare Clinical Research

    Tampa, Florida, 33613

    Active, not recruiting

  • Physicians Research Group

    Tempe, Arizona, 85284

    Active, not recruiting

  • Prime Global Research, LLC

    The Bronx, New York, 10456

    Terminated

  • Lynn Institute of Tulsa

    Tulsa, Oklahoma, 74135

    Active, not recruiting

  • Pacific Clinical Research Management Group LLC

    Upland, California, 91786

    Active, not recruiting

  • Sunwise Clinical Research

    Walnut Creek, California, 94596

    Recruiting

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

    Active, not recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Recruiting

  • Integrated Clinical Trial Services

    West Des Moines, Iowa, 50265

    Recruiting

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

    Active, not recruiting

  • Options Research Group, LLC

    Westfield, Indiana, 46074

    Recruiting

  • Nemours Children's Hospital, Delaware

    Wilmington, Delaware, 19803

    Active, not recruiting

Other trials in United States

China38 sites, 26 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100089

    Active, not recruiting

  • First Affiliated Hospital of Bengbu Medical College Neurology

    Bengbu, Anhui, 233000

    Active, not recruiting

  • The First Hospital of Jilin University, Pediatric Neurology

    Changchun, Jilin, 130021

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

    Recruiting

  • Hunan Children's Hospital

    Changsha, Hunan, 410007

    Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Active, not recruiting

  • " The First Affiliated Hospital of Chongqing Medical University"

    Chongqing, Chongqing Municipality, 400042

    Recruiting

  • Hainan General Hospital

    Haikou, Hainan, 571140

    Active, not recruiting

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

    Recruiting

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong, 250013

    Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei, 434000

    Active, not recruiting

  • Lanzhou university second hospital

    Lanzhou, Gansu, 730030

    Active, not recruiting

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222002

    Recruiting

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

    Recruiting

  • Lu 'an People's Hospital

    Lu'an

    Recruiting

  • Ningbo Women and Children's Hospital

    Ningbo, Zhejiang, 315012

    Active, not recruiting

  • Children's Hospital of Shanghai

    Shanghai

    Active, not recruiting

  • Shengjing Hospital of China Medical University

    Shenyang

    Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518034

    Recruiting

  • The First Affiliated Hospital of Shihezi University School of Medicine

    Shihezi

    Active, not recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050004

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Active, not recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Recruiting

  • Wuhan Children's Hospital

    Wuhan

    Recruiting

  • Wuxi Children's Hospital

    Wuxi, Jiangsu, 214023

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214115

    Recruiting

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

    Active, not recruiting

  • Xi'an Gaoxin Hospital Neurology Department

    Xi'an, Shaanxi, 710075

    Active, not recruiting

  • Yan 'an University Xianyang Hospital

    Xianyang, Shaanxi, 716000

    Recruiting

  • Xuzhou Children's Hospital

    Xuzhou, Jiangsu, 221002

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 756000

    Recruiting

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000

    Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

    Recruiting

Other trials in China

Japan13 sites, 12 recruiting

  • Tennoji Dai Brain Clinic

    Abeno-ku Osaka-shi, Osaka, 545-0053

    Recruiting

  • Konan Medical Center

    Higashinada-ku Kobe-shi, Hyōgo, 658-0064

    Recruiting

  • Local lndependent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City

    Hiroshima, 730-8518

    Active, not recruiting

  • Tanaka Neurosurgery & Headache Clinic

    Kagoshima, Kagoshima-ken, 890-0052

    Recruiting

  • Jinnouchi Neurosurgical Clinic

    Kasuga-shi, Fukuoka, 816-0802

    Recruiting

  • Ikeda Neurosurgical Clinic

    Kasuga-shi, Fukuoka, 816-0824

    Recruiting

  • Hikita Pediatric Clinic

    Kiryu-shi, Gunma, 3760035

    Recruiting

  • Mito Kyodo General Hospital

    Mito, Ibaraki, 310-0015

    Recruiting

  • Tominaga Clinic

    Naniwa-ku, Osaka, 556-0015

    Recruiting

  • Yamaguchi Clinic

    Nishinomiya-shi, Hyōgo, 663-8204

    Recruiting

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo, 151-0051

    Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

    Recruiting

  • Sendai Headache and Neurology Clinic

    Taihaku-ku Sendai-shi, Miyagi, 982-0014

    Recruiting

Other trials in Japan

Poland8 sites, 6 recruiting

  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski

    Katowice, 40-123

    Active, not recruiting

  • Centrum Medyczne Plejady

    Krakow, 30-363

    Recruiting

  • Oddzial Kliniczny Dzieci Starszych z Pododdzialami: Neurologicznym, Reumatologicznym

    Krakow, 31-503

    Recruiting

  • Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, Apteka Szpitalna

    Krakow, 31-503

    Recruiting

  • Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie

    Krakow, 31-503

    Recruiting

  • Clinical Research Center Sp. z.o.o. Medic-R Spolka komandytowa

    Poznan, 61-731

    Recruiting

  • Euromedis Sp. z o. o.

    Szczecin, 70-111

    Active, not recruiting

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, Lower Silesian Voivodeship, 52-210

    Recruiting

Other trials in Poland

Spain6 sites, 2 recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Centre d'Atencio Primaria Balenya

    Barcelona, 08550

    Active, not recruiting

  • Instituto de Investigaciones del Sueno

    Madrid, 28036

    Active, not recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

    Active, not recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Active, not recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005

    Recruiting

Other trials in Spain

Mexico4 sites, 2 recruiting

  • Unidad de Investigacion en Salud de Chihuahua S.C.

    Chihuahua City, 31203

    Active, not recruiting

  • Clinstile S.A. de C.V.

    Col. Roma Norte, Mexico City, C.P. 06700.

    Recruiting

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 800200

    Active, not recruiting

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About this study

Official title: Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

Being tested
Rimegepant/BHV3000, Matching placebo
Keywords
Migraine, Acute treatment, Phonophobia, Photophobia, Nausea, Pediatric, Children, Adolescent, Pediatric Migraine
Medical subject headings
Migraine Disorders, Hyperacusis, Photophobia, Nausea

What participants receive

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

  • Rimegepant/BHV3000Drug

    BHV3000 (rimegepant) 75 mg or 50 mg ODT

  • Matching placeboDrug

    Matching 75 mg or 50 mg ODT placebo

Study groups in NCT04649242
Study groupRoleWhat they receive
BHV3000 (active drug)Active comparatorBHV3000 (rimegepant) 75 mg or 50 mg ODT
Receives: Drug: Rimegepant/BHV3000
PlaceboPlacebo comparatorMatching 75 mg or 50 mg ODT placebo
Receives: Drug: Matching placebo

What is being measured

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

  1. To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.

    Pain freedom will be assessed in adolescent population (≥ 12 to < 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).

    Measured: 2 hours post-dose

Secondary outcomes (16)

  1. To compare rimegepant with placebo for pain freedom in children and adolescents combined.

    Pain freedom will be assessed in children and adolescents (≥ 6 to < 18 years of age) using a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).

    Pain freedom will be assessed in children (> 6 to < 12 years of age) using the 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').

    Measured: 2 hours post-dose

  2. To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.

    Freedom from MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present).

    Measured: 2 hours post-dose

  3. To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.

    Use of rescue medication will be assessed using the numbers of participants that take rescue medication.

    Measured: Within 24 hours and 48 hours of initial treatment

  4. To compare rimegepant with placebo on sustained pain freedom in adolescents.

    Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.

    Measured: 2 to 24 hours post-dose

  5. To compare rimegepant with placebo on sustained pain freedom in adolescents.

    Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.

    Measured: 2 to 48 hours post-dose

  6. To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents.

    The proportion of participants able to function normally will be assessed using the number that self-report as "normal" on the Functional Disability scale.

    Measured: 2 hours post-dose

  7. To compare rimegepant with placebo for pain freedom in children.

    Pain freedom will be assessed using the number of children (≥ 6 to < 12 years of age) that report no pain measured by a 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').

    Measured: 2 hours post-dose

  8. To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents.

    Freedom from the most bothersome symptom (nausea, phonophobia or photophobia) will be assessed using the number of participants that report the absence of MBS measured using a binary scale (0=absent, 1=present).

    Measured: 2 hours post-dose

  9. To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents.

    The probabilities of requiring rescue medication will be assessed using the numbers of participants that take rescue medication within initial treatment.

    Measured: Within 24 hours and 48 hours of initial treatment.

  10. To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.

    Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.

    Measured: 2 to 24 hours post-dose

  11. To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.

    Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.

    Measured: 2 to 48 hours post-dose

  12. To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents.

    Freedom from photophobia will be assessed by the number of participants that report the absence of photophobia post dose that reported the presence of photophobia at baseline.

    Measured: 2 hours post-dose

  13. To compare rimegepant with placebo on freedom from phonophobia in adolescents, children and combined children and adolescents.

    Freedom from phonophobia will be assessed by the number of participants that report the absence of phonophobia post dose that reported the presence of phonophobia at baseline.

    Measured: 2 hours post-dose

  14. To compare rimegepant with placebo on freedom from nausea in adolescents, children and combined children and adolescents.

    Freedom from nausea will be assessed by the number of participants that report the absence of nausea post dose that reported the presence of nausea at baseline.

    Measured: 2 hours post-dose

  15. To compare rimegepant with placebo on pain relief in adolescents, children and combined children and adolescents.

    Pain relief will be assessed using the number of participants that report a pain level of moderate or severe at baseline and then report a pain level of none or mild post dose.

    Measured: 2 hours post-dose

  16. To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief.

    Time to first report of pain relief will be based on the first time point a participant reports a pain level of none or mild.

    Measured: Time to patients first report of pain relief of none or mild post dose up to 48 hours.

Timeline

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

  1. First posted2 Dec 2020
  2. Study start15 Jan 2021
  3. Primary completion9 Jan 2029 (estimated)
  4. Study completion9 Jan 2029 (estimated)

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
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04649242
Sponsor's protocol ID
BHV3000-311
Other IDs
C4951002, 2020-003517-35, 2024-512743-23-00
Status last verified
Oct 2026
First submitted
23 Nov 2020
Last updated
27 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rimegepant/BHV3000 in people with Pediatric Migraine, run by Pfizer at 246 sites in 9 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 246 sites in United States, China, Japan, Poland, Spain and 4 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Pfizer Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain. (time frame: 2 hours post-dose). 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 NCT04649242.

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 27 Oct 2026.

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