Randomized Study in Children and Adolescents With Migraine: Acute Treatment

June 4, 2026 updated by: Pfizer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Kelowna BC, British Columbia, Canada, V1Y 5A8
        • Recruiting
        • Kelowna Health & Memory Centre
    • Quebec
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Active, not recruiting
        • Diex Recherche Sherbrooke Inc
  • China
      • Lu'an, China
        • Recruiting
        • Lu 'an People's Hospital
      • Shanghai, China
        • Recruiting
        • Children's Hospital of Shanghai
      • Shenyang, China
        • Recruiting
        • Shengjing Hospital of China Medical University
      • Shihezi, China
        • Active, not recruiting
        • The First Affiliated Hospital of Shihezi University School of Medicine
      • Wuhan, China
        • Recruiting
        • Wuhan Children's Hospital
    • Anhui
      • Bengbu, Anhui, China, 233000
        • Recruiting
        • First Affiliated Hospital of Bengbu Medical College Neurology
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Anhui Provincial Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100089
        • Recruiting
        • Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400042
        • Recruiting
        • " The First Affiliated Hospital of Chongqing Medical University"
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • Lanzhou University Second Hospital
    • Guangdong
      • Shenzhen, Guangdong, China, 518034
        • Recruiting
        • Shenzhen Children's Hospital
    • Hainan
      • Haikou, Hainan, China, 571140
        • Recruiting
        • Hainan General Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The First Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 050004
        • Recruiting
        • The Second Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • People's Hospital of Zhengzhou
    • Hubei
      • Jingzhou, Hubei, China, 434000
        • Recruiting
        • Jingzhou First People's Hospital
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410000
        • Recruiting
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410007
        • Recruiting
        • Hunan Children's Hospital
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222002
        • Recruiting
        • The Second People's Hospital of Lianyungang
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China, 214115
        • Recruiting
        • Affiliated Hospital of Jiangnan University
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi Children's Hospital
      • Xuzhou, Jiangsu, China, 221002
        • Recruiting
        • Xuzhou Children's Hospital
      • Zhenjiang, Jiangsu, China, 212001
        • Recruiting
        • Affiliated Hospital of Jiangsu University
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University, Pediatric Neurology
    • Ningxia
      • Yinchuan, Ningxia, China, 756000
        • Recruiting
        • General Hospital of Ningxia Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
      • Xi'an, Shaanxi, China, 710075
        • Recruiting
        • Xi'an Gaoxin Hospital Neurology Department
      • Xianyang, Shaanxi, China, 716000
        • Recruiting
        • Yan 'an University Xianyang Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Shandong Provincial Qianfoshan Hospital
      • Liaocheng, Shandong, China, 252000
        • Recruiting
        • Liaocheng People's Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310052
        • Recruiting
        • Children's Hospital of Zhejiang University School of Medicine
      • Ningbo, Zhejiang, China, 315012
        • Recruiting
        • Ningbo Women and Children's Hospital
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
  • Japan
      • Hiroshima, Japan, 730-8518
        • Recruiting
        • Local lndependent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City
    • Fukuoka
      • Kasuga-shi, Fukuoka, Japan, 816-0802
        • Recruiting
        • Jinnouchi Neurosurgical Clinic
      • Kasuga-shi, Fukuoka, Japan, 816-0824
        • Recruiting
        • Ikeda Neurosurgical Clinic
    • Gunma
      • Kiryu-shi, Gunma, Japan, 3760035
        • Recruiting
        • Hikita Pediatric Clinic
    • Hyōgo
      • Higashinada-ku Kobe-shi, Hyōgo, Japan, 658-0064
        • Recruiting
        • Konan Medical Center
      • Nishinomiya-shi, Hyōgo, Japan, 663-8204
        • Recruiting
        • Yamaguchi Clinic
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0015
        • Recruiting
        • Mito Kyodo General Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0052
        • Recruiting
        • Tanaka Neurosurgery & Headache Clinic
    • Miyagi
      • Taihaku-ku Sendai-shi, Miyagi, Japan, 982-0014
        • Recruiting
        • Sendai Headache and Neurology Clinic
    • Osaka
      • Abeno-ku Osaka-shi, Osaka, Japan, 545-0053
        • Recruiting
        • Tennoji Dai Brain Clinic
      • Naniwa-ku, Osaka, Japan, 556-0015
        • Recruiting
        • Tominaga Clinic
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 151-0051
        • Recruiting
        • Tokyo Headache Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Not yet recruiting
        • Tokyo Medical University Hospital
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Recruiting
        • Unidad de Investigación en Salud de Chihuahua S.C.
    • Mexico City
      • Col. Roma Norte, Mexico City, Mexico, C.P. 06700.
        • Recruiting
        • Clinstile S.A. de C.V.
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 800200
        • Recruiting
        • Neurociencias Estudios Clinicos S.C.
    • State of Mexico
      • Tlalnepantla, State of Mexico, Mexico, C.P. 54055
        • Recruiting
        • Clinical Reseach Institute, S.C.
  • Poland
      • Katowice, Poland, 40-123
        • Active, not recruiting
        • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
      • Krakow, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
        • Contact:
      • Krakow, Poland, 31-503
        • Recruiting
        • Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
      • Krakow, Poland, 31-503
        • Recruiting
        • Oddzial Kliniczny Dzieci Starszych z Pododdzialami: Neurologicznym, Reumatologicznym
      • Krakow, Poland, 31-503
        • Recruiting
        • Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, Apteka Szpitalna
      • Poznan, Poland, 61-731
        • Recruiting
        • Clinical Research Center Sp. z.o.o. Medic-R Spolka komandytowa
      • Szczecin, Poland, 70-111
        • Active, not recruiting
        • Euromedis Sp. z o. o.
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Recruiting
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08550
        • Active, not recruiting
        • Centre d'Atencio Primaria Balenya
      • Madrid, Spain, 28036
        • Active, not recruiting
        • Instituto de Investigaciones del Sueño
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Valladolid, Spain, 47005
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Active, not recruiting
        • Hospital Universitario Marques de Valdecilla
  • Sweden
      • Stockholm, Sweden, 113 29
        • Recruiting
        • ProbarE i Stockholm AB
      • Örebro, Sweden, 703 62
        • Active, not recruiting
        • Avdelningen för kliniska Prövningar, Universitetssjukhuset Örebro
    • Skåne LÄN [se-12]
      • Lund, Skåne LÄN [se-12], Sweden, 22222
        • Recruiting
        • ProbarE i Lund AB
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Active, not recruiting
        • Leicester Royal Infirmary
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children NHS Foundation Trust
      • London, United Kingdom, W1G 9JF
        • Recruiting
        • Re:Cognition Health Limited
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Active, not recruiting
        • Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85253
        • Recruiting
        • Perseverance Research Center, LLC
      • Tempe, Arizona, United States, 85284
        • Active, not recruiting
        • Physicians Research Group
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center, Inc.
      • Costa Mesa, California, United States, 92627
        • Recruiting
        • Adult & Child Neurology Medical Associates
      • Culver City, California, United States, 90230
        • Active, not recruiting
        • ProScience Research Group
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Memorial Health Services
      • Fresno, California, United States, 93710
        • Recruiting
        • Neuro-Pain Research Center
      • La Jolla, California, United States, 93037
        • Recruiting
        • Altman Clinical and Translational Research Institute, University of California San Diego
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's & Women's Hospital Long Beach
      • Long Beach, California, United States, 90806
        • Recruiting
        • Adult & Child Neurology Medical Associates
      • Los Angeles, California, United States, 90057
        • Active, not recruiting
        • National Research Institute
      • North Hollywood, California, United States, 91606
        • Active, not recruiting
        • Velocity Clinical Research - North Hollywood
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Children's Hospital of Orange County
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Children's Hospital of Orange County - Inpatient Pharmacy
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Children's Hospital of Orange County - Neuroscience Center
      • Pomona, California, United States, 91767
        • Recruiting
        • The Neurology Group
        • Contact:
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
      • Sacramento, California, United States, 95816
        • Active, not recruiting
        • University of California, Davis Midtown Clinic
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
      • San Bernardino, California, United States, 92408
        • Recruiting
        • Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)
      • Upland, California, United States, 91786
        • Active, not recruiting
        • Pacific Clinical Research Management Group LLC
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Sunwise Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado- lnvestigational Drug Services
      • Colorado Springs, Colorado, United States, 80907
        • Active, not recruiting
        • Colorado Springs Neurological Associates, PC
      • Colorado Springs, Colorado, United States, 80919
        • Active, not recruiting
        • Colorado Springs Neurological Associates, PC
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • CT Clinical Research
      • Hartford, Connecticut, United States, 06106
        • Active, not recruiting
        • Connecticut Children's Medical Center
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • Ki Health Partners, LLc, dba New England Institute for Clinical Research
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Active, not recruiting
        • Nemours Children's Hospital, Delaware
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
    • Florida
      • Apopka, Florida, United States, 32703
        • Active, not recruiting
        • Topaz Clinical Research, Inc.
      • Cutler Bay, Florida, United States, 33157
        • Terminated
        • Beautiful Minds Clinical Research Center
      • DeLand, Florida, United States, 32720
        • Terminated
        • DeLand Clinical Research Unit
      • Gainesville, Florida, United States, 32607
        • Active, not recruiting
        • Sarkis Clinical Trials
      • Lake City, Florida, United States, 32055
        • Active, not recruiting
        • Multi-Specialty Research Associates, Inc.
      • Lakeland, Florida, United States, 33805
        • Terminated
        • Watson Clinic Center for Research, Inc.
      • Lakeland, Florida, United States, 33805
        • Terminated
        • Watson Clinic LLP
      • Miami, Florida, United States, 33176
        • Active, not recruiting
        • Brainstorm Research
      • Miami, Florida, United States, 33134
        • Active, not recruiting
        • Medical Research Center of Miami II, Inc
      • Miami, Florida, United States, 33126
        • Active, not recruiting
        • AppleMed Research Group, LLC
      • Miami, Florida, United States, 33166
        • Recruiting
        • South Florida Research Phase I-IV, Inc
      • Naples, Florida, United States, 34105
        • Recruiting
        • Aqualane Clinical Research
      • Naples, Florida, United States, 34102
        • Active, not recruiting
        • Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office
      • Orange Park, Florida, United States, 32073
        • Active, not recruiting
        • Coastal Clinical Research Specialists
      • Orlando, Florida, United States, 32819
      • Pembroke Pines, Florida, United States, 33026
        • Terminated
        • Bioresearch Institute
      • Tampa, Florida, United States, 33613
        • Active, not recruiting
        • ForCare Clinical Research
      • West Palm Beach, Florida, United States, 33407
        • Active, not recruiting
        • Premiere Research Institute at Palm Beach Neurology
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Childrens Healthcare of Atlanta
      • Atlanta, Georgia, United States, 30329
        • Active, not recruiting
        • Rare Disease Research, LLC
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta, Inc.
      • Brunswick, Georgia, United States, 31520
        • Recruiting
        • Pivotal Clinical Research & Associates, LLC
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Chicago Headache Center & Research Institute
      • Naperville, Illinois, United States, 60563
        • Recruiting
        • AMR-Baber Research Inc
    • Indiana
      • Westfield, Indiana, United States, 46074
        • Recruiting
        • Options Research Group, LLC
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Recruiting
        • Velocity Clinical Research, Sioux City
      • West Des Moines, Iowa, United States, 50265
        • Recruiting
        • Integrated Clinical Trial Services
    • Kansas
      • Kansas City, Kansas, United States, 66214
        • Recruiting
        • Clinical Associates Midwest, LLC
      • Overland Park, Kansas, United States, 66212
        • Active, not recruiting
        • College Park Family Care Center Physicians Group- Neurology Research Dept.
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Active, not recruiting
        • Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Active, not recruiting
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, United States, 71105
        • Active, not recruiting
        • Neurology and Headache Center, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Active, not recruiting
        • Boston Clinical Trials
      • Waltham, Massachusetts, United States, 02451
        • Active, not recruiting
        • MedVadis Research Corporation
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • Michigan Head Pain & Neurological Institute
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health, Helen DeVos Children's Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Active, not recruiting
        • Wellnow Urgent Care and Research
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont Hospital Royal Oak Campus
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Brackenridge Outpatient Research Pharmacy
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Clinical Research Trials Unit
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Precise Research Centers
    • Missouri
      • Ozark, Missouri, United States, 65721
        • Active, not recruiting
        • Sharlin Health Neuroscience Research Center
      • Springfield, Missouri, United States, 65810
        • Active, not recruiting
        • Clinvest Research, LLC
    • Montana
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Boeson Research
      • Kalispell, Montana, United States, 59901
        • Active, not recruiting
        • Heart & Hands Midwifery
      • Kalispell, Montana, United States, 59901
        • Active, not recruiting
        • Boeson Research
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Boeson Research
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Blue Moose Pediatrics
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Boeson Research Laboratory
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Terminated
        • Alivation Research, LLC.
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital & Medical Center
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • HMH Jersey Shore University Medical Center
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • HOPE Tower at Jersey Shore University Medical Center
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurosciences Research Center
      • Commack, New York, United States, 11725
        • Recruiting
        • True North Neurology
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/ Division of Pediatric Neurology
      • Mineola, New York, United States, 11501
        • Active, not recruiting
        • NYU Langone Hospital-Long Island, Clinical Research Center
      • Mineola, New York, United States, 11501
        • Active, not recruiting
        • NYU Langone Hospital-Long Island, Pediatric Neurology
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine
      • New York, New York, United States, 10003
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Mount Sinai Hospital - Pharmacy Department
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University Medical Center Research Pharmacy
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University Pediatric Neuromuscular Center
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
      • New York, New York, United States, 10032
        • Active, not recruiting
        • The Neurological Institute of New York
      • New York, New York, United States, 10032
        • Active, not recruiting
        • The Trustees of Columbia University and The New York and Presbyterian Hospital
      • Port Jefferson Station, New York, United States, 11776
        • Active, not recruiting
        • North Suffolk Neurology P.C
      • Rochester, New York, United States, 14618
        • Terminated
        • Finger Lakes Clinical Research
      • The Bronx, New York, United States, 10456
        • Terminated
        • Prime Global Research, LLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Onsite Clinical Solutions, LLC
      • Charlotte, North Carolina, United States, 28211
        • Active, not recruiting
        • New Hope Clinical Research
      • Durham, North Carolina, United States, 27701
        • Recruiting
        • Velocity Clinical Research, Inc.
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Headache Wellness Center, PC
    • Ohio
      • Akron, Ohio, United States, 44308
        • Active, not recruiting
        • Akron Children's Hospital
      • Cincinnati, Ohio, United States, 45229
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Velocity Clinical Research
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43205
        • Active, not recruiting
        • Nationwide Children's Hospital
      • Columbus, Ohio, United States, 43228
        • Active, not recruiting
        • Wellnow Urgent Care and Research
      • North Canton, Ohio, United States, 44720
        • Active, not recruiting
        • Neuro-Behavioral Clinical Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Active, not recruiting
        • IPS Research Company
      • Tulsa, Oklahoma, United States, 74135
        • Active, not recruiting
        • Lynn Institute of Tulsa
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Active, not recruiting
        • Velocity Clinical Research, Grants Pass
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Neuroscience Institute - Research Coordinator's Office
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19103
        • Recruiting
        • Clario
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research-Providence
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Active, not recruiting
        • Tribe Clinical Research, LLC
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Premier Neurology, PC
      • Greenville, South Carolina, United States, 29615
        • Active, not recruiting
        • Velocity Clinical Research - Greenville
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Active, not recruiting
        • Holston Medical Group
      • Kingsport, Tennessee, United States, 37660
        • Active, not recruiting
        • Holston Medical Group.
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital - Outpatient Building
      • Nashville, Tennessee, United States, 37203
        • Active, not recruiting
        • Access Clinical Trials, Inc.
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's Medical Center
      • Austin, Texas, United States, 78749
        • Recruiting
        • Child Neurology Consultants of Austin - South Austin
      • Austin, Texas, United States, 78757
        • Recruiting
        • Child Neurology Consultants of Austin - Central Austin
      • Austin, Texas, United States, 78759
        • Active, not recruiting
        • BioBehavioral Research of Austin
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Houston Clinical Trials, LLC
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • The University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75251
        • Active, not recruiting
        • Cedar Health Research
      • Dallas, Texas, United States, 75251
        • Recruiting
        • FutureSearch Trials of Dallas, LLC
      • Dallas, Texas, United States, 75201
        • Active, not recruiting
        • Infinite Research Group, LLC
      • Dallas, Texas, United States, 75235
        • Active, not recruiting
        • Children's Medical Center, Dallas
      • Dallas, Texas, United States, 75235
        • Active, not recruiting
        • Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
      • El Paso, Texas, United States, 79912
        • Recruiting
        • ANESC Research
      • Frisco, Texas, United States, 75034
        • Active, not recruiting
        • North Texas Institute of Neurology and Headache
      • Houston, Texas, United States, 77054
        • Recruiting
        • Pain and Headache Centers of Texas
        • Contact:
      • Houston, Texas, United States, 77094
        • Recruiting
        • NeuroCare Plus
      • Houston, Texas, United States, 77030
        • Recruiting
        • UTHealth Houston
      • Houston, Texas, United States, 77081
        • Active, not recruiting
        • Houston Clinical Research,LLC.
      • Houston, Texas, United States, 77077
        • Recruiting
        • SCLA Management
      • Plano, Texas, United States, 75093
        • Recruiting
        • Aim Trials, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • JBR Clinical Research
        • Contact:
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Wasatch Clinical Research , LLC(Administrative Location)
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Active, not recruiting
        • The University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Recruiting
        • Pediatric Research of Charlottesville, LLC
        • Contact:
      • Charlottesville, Virginia, United States, 22902
        • Recruiting
        • Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
      • Charlottesville, Virginia, United States, 22902
        • Recruiting
        • Pediatric Research of Charlottesville, LLC (Regulatory Only)
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters
      • Norfolk, Virginia, United States, 23510
        • Recruiting
        • Children's Specialty Group, PLLC, Division of Childhood & Adolescent Neurology
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Specialty Group, PLLC
      • Richmond, Virginia, United States, 23294
        • Active, not recruiting
        • National Clinical Research, Inc.
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
      • Everett, Washington, United States, 98201
        • Active, not recruiting
        • Eastside Therapeutic Resource, Inc. dba Core Clinical Research
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital Investigational Drug Services
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Recruiting
        • Clinical Investigation Specialists, Inc
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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).
  2. 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.

  3. 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.

    1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.
    2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
    3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
  4. Verbally distinguish between migraine and other types of headaches.
  5. Participants must have a weight > 40 kg at the Screening Visit.
  6. Adequate venous access for blood sampling.
  7. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
  3. 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.
  4. History of suicidal behavior or major psychiatric disorder.
  5. Current diagnosis or history of substance abuse; positive drug test at Screening.
  6. 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.
  7. Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
  8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
  9. Current diagnosis of viral hepatitis or a history of liver disease.
  10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BHV3000 (active drug)
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Drug: Rimegepant/BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Placebo Comparator: Placebo
Matching 75 mg or 50 mg ODT placebo
Drug: Matching placebo
Matching 75 mg or 50 mg ODT placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
2 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare rimegepant with placebo for pain freedom in children and adolescents combined.
Time Frame: 2 hours post-dose

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').
2 hours post-dose
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
Time Frame: 2 hours post-dose
Freedom from MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present).
2 hours post-dose
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
Time Frame: Within 24 hours and 48 hours of initial treatment
Use of rescue medication will be assessed using the numbers of participants that take rescue medication.
Within 24 hours and 48 hours of initial treatment
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Time Frame: 2 to 24 hours post-dose
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.
2 to 24 hours post-dose
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Time Frame: 2 to 48 hours post-dose
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.
2 to 48 hours post-dose
To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents.
Time Frame: 2 hours post-dose
The proportion of participants able to function normally will be assessed using the number that self-report as "normal" on the Functional Disability scale.
2 hours post-dose
To compare rimegepant with placebo for pain freedom in children.
Time Frame: 2 hours post-dose
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').
2 hours post-dose
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents.
Time Frame: 2 hours post-dose
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).
2 hours post-dose
To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents.
Time Frame: Within 24 hours and 48 hours of initial treatment.
The probabilities of requiring rescue medication will be assessed using the numbers of participants that take rescue medication within initial treatment.
Within 24 hours and 48 hours of initial treatment.
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
Time Frame: 2 to 24 hours post-dose
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.
2 to 24 hours post-dose
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
Time Frame: 2 to 48 hours post-dose
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.
2 to 48 hours post-dose
To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents.
Time Frame: 2 hours post-dose
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.
2 hours post-dose
To compare rimegepant with placebo on freedom from phonophobia in adolescents, children and combined children and adolescents.
Time Frame: 2 hours post-dose
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.
2 hours post-dose
To compare rimegepant with placebo on freedom from nausea in adolescents, children and combined children and adolescents.
Time Frame: 2 hours post-dose
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.
2 hours post-dose
To compare rimegepant with placebo on pain relief in adolescents, children and combined children and adolescents.
Time Frame: 2 hours post-dose
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.
2 hours post-dose
To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief.
Time Frame: Time to patients first report of pain relief of none or mild post dose up to 48 hours.
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.
Time to patients first report of pain relief of none or mild post dose up to 48 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Estimated)

January 9, 2029

Study Completion (Estimated)

January 9, 2029

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

November 30, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV3000-311
  • C4951002 (Other Identifier: Alias Study Number)
  • 2020-003517-35 (Registry Identifier: CTIS (EU))
  • 2024-512743-23-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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