Randomized Study in Children and Adolescents With Migraine: Acute Treatment

April 10, 2024 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

Pediatric Migraine

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

Name: Pfizer Pfizer CT.gov Call Center
Phone Number: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

Canada
- - Quebec, Canada, G3K 2P8
    - Not yet recruiting
    - Alpha Recherche Clinique
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 1Z9
    - Recruiting
    - OCT Research ULC
- Quebec
  - Sherbrooke, Quebec, Canada, J1L 0H8
    - Recruiting
    - Diex Recherche Sherbrooke Inc
China
- - Chifeng, China
    - Recruiting
    - Affiliated Hospital of Chifeng University
  - Chongqing, China, 404000
    - Recruiting
    - Chongqing University Three Gorges Hospital
  - 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
    - 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
  - Beijing, Beijing, China, 100089
    - Recruiting
    - Chinese PLA General Hospital
- Chongqing
  - Chongqing, Chongqing, China, 400016
    - Recruiting
    - " The First Affiliated Hospital of Chongqing Medical University"
  - Chongqing, Chongqing, China, 400042
    - Recruiting
    - " The First Affiliated Hospital of Chongqing Medical University"
- Gansu
  - Lanzhou, Gansu, China, 730030
    - Recruiting
    - Lanzhou university second hospital
  - Lanzhou, Gansu, China, 730030
    - Recruiting
    - Lanzhou University Second Hospital Lab
- Guangdong
  - Shenzhen, Guangdong, China, 518026
    - Recruiting
    - Shenzhen Children's Hospital
  - Shenzhen, Guangdong, China, 518034
    - Recruiting
    - Shenzhen Children's Hospital
- Hainan
  - Haikou, Hainan, China, 570100
    - Recruiting
    - Hainan General Hospital
  - 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
  - Shijiazhuang, Hebei, China, 05000
    - Recruiting
    - The First Hospital Of Hebei Medical University
- Henan
  - Zhengzhou, Henan, China, 450000
    - Recruiting
    - People's Hospital of Zhengzhou
  - Zhengzhou, Henan, China, 450014
    - Recruiting
    - People's Hospital of Zhengzhou
- Hubei
  - Jingzhou, Hubei, China, 434000
    - Recruiting
    - Jingzhou First People's Hospital
  - Wuhan, Hubei, China, 430022
    - Recruiting
    - Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  - Wuhan City, Hubei, China, 430060
    - Recruiting
    - Renmin Hospital of Wuhan University
- Hunan
  - Changsha, Hunan, China, 410013
    - Recruiting
    - The Third Xiangya Hospital of Central South University
  - Changsha, Hunan, China, 410011
    - Recruiting
    - The Second 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, 750004
    - Recruiting
    - General Hospital of Ningxia Medical University
  - Yinchuan, Ningxia, China, 750000
    - 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 City, Shaanxi, China, 716000
    - Recruiting
    - Yan 'an University Xianyang Hospital
- Shandong
  - Jinan, Shandong, China, 250013
    - Recruiting
    - ShanDong Provincial QianFoShan Hospital
  - Jinan, Shandong, China, 250014
    - 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
    - Not yet recruiting
    - Ningbo Women And Children's Hospital
  - 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
    - Not yet recruiting
    - Local lndependent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City
- Ehime
  - Matsuyama-shi, Ehime, Japan, 790-0925
    - Not yet recruiting
    - Medical Corporation Seikokai Takanoko Hospital
- Fukuoka
  - Kasuga-shi, Fukuoka, Japan, 816-0802
    - Not yet recruiting
    - Jinnouchi Neurosurgical Clinic
  - Kasuga-shi, Fukuoka, Japan, 816-0824
    - Not yet recruiting
    - Ikeda Neurosurgical Clinic
- Gunma
  - Kiryu-shi, Gunma, Japan, 3760035
    - Not yet recruiting
    - Hikita Pediatric clinic
- Hiroshima
  - Naka-ku Hiroshima-shi, Hiroshima, Japan, 730-8518
    - Not yet recruiting
    - Hiroshima City Hiroshima Citizens Hospital
- Hyogo
  - Nishinomiya-shi, Hyogo, Japan, 663-8204
    - Not yet recruiting
    - Yamaguchi Clinic
- Hyōgo
  - Higashinada-ku Kobe-shi, Hyōgo, Japan, 658-0064
    - Not yet recruiting
    - Konan Medical Center
  - Nishinomiya-shi, Hyōgo, Japan, 663-8204
    - Not yet recruiting
    - Yamaguchi Clinic
- Ibaraki
  - Mito-shi, Ibaraki, Japan, 310-0015
    - Not yet recruiting
    - Mito Kyodo General Hospital
- Kagoshima
  - Kagoshima-shi, Kagoshima, Japan, 892-0844
    - Not yet recruiting
    - Tanaka Neurosurgical Clinic
- Miyagi
  - Taihaku-ku Sendai-shi, Miyagi, Japan, 982-0014
    - Not yet recruiting
    - Sendai Headache and Neurology Clinic
- Osaka
  - Abeno-ku Osaka-shi, Osaka, Japan, 545-0053
    - Not yet recruiting
    - Tennoji Dai Brain Clinic
  - Naniwa-ku, Osaka-shi, Osaka, Japan, 556-0015
    - Not yet recruiting
    - Tominaga Clinic
- Tokyo
  - Shibuya-ku, Tokyo, Japan, 151-0051
    - Not yet recruiting
    - Tokyo Headache Clinic
  - Shinjuku-ku, Tokyo, Japan, 160-0023
    - Not yet recruiting
    - Tokyo Medical University Hospital
Mexico
- - Chihuahua, Mexico, 31203
    - Recruiting
    - Unidad de Investigacion en Salud de Chihuahua S.C.
- Ciudad DE Mexico
  - Col. Roma Norte, Ciudad DE Mexico, Mexico, C.P. 06700.
    - Recruiting
    - Clinstile S.A. de C.V.
- Estado DE Mexico
  - Tlalnepantla de Baz, Estado DE Mexico, Mexico, C.P. 54055
    - Recruiting
    - Clinical Reseach Institute, S.C.
- Jalisco
  - Zapopan, Jalisco, Mexico, 45070
    - Recruiting
    - Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
- Nuevo LEON
  - Monterrey, Nuevo LEON, Mexico, 64460
    - Not yet recruiting
    - "Hospital Universitario "" Dr. Jose Eleuterio Gonzalez"" Edificio Barragan 3er Piso CITEN
- Nuevo LEÓN
  - Monterrey, Nuevo LEÓN, Mexico, C.P. 64610.
    - Recruiting
    - CIT-Neuropsique, S.C.
- Sinaloa
  - Culiacan, Sinaloa, Mexico, 800200
    - Recruiting
    - Neurociencias Estudios Clinicos S.C.
Poland
- - Katowice, Poland, 10-123
    - Recruiting
    - NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
  - Katowice, Poland, 40-123
    - Active, not recruiting
    - NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
  - Krakow, Poland, 31-503
    - Recruiting
    - Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
    - Contact:
      
      Barbara Prawdzic-Senkowska
      
      Phone Number: (+48) 126198651
      
      Email: barbara.senkowska@interia.pl
  - Krakow, Poland, 31-503
    - Recruiting
    - Wojewodzki 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
  - Poznań, Poland, 61-731
    - Recruiting
    - Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k.
  - Szczecin, Poland, 70-111
    - Active, not recruiting
    - Euromedis Sp. z o. o.
  - Wroclaw, Poland, 52-416
    - Recruiting
    - Centrum Medyczne Oporow
    - Contact:
      
      PIOTR KLEPACKI
      
      Phone Number: 48501104244
      
      Email: piotr.klepacki@cmoporow.com
- Dolnoslaskie
  - Wroclaw, Dolnoslaskie, Poland, 52-210
    - Recruiting
    - Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitari Vall dHebron
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitario Vall d'Hebron
  - Barcelona, Spain, 08550
    - Active, not recruiting
    - CAP Balenyà
  - Barcelona, Spain, 08550
    - Active, not recruiting
    - Centre d'Atencio Primaria Balenya
  - Madrid, Spain, 28036
    - Active, not recruiting
    - Instituto de Investigaciones del Sueño
  - Santander, Spain, 39008
    - Active, not recruiting
    - Hospital Universitario Marqués de Valdecilla
  - Sevilla, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen Del Rocio
  - Valladolid, Spain, 47005
    - Recruiting
    - Hospital Clínico Universitario de Valladolid
    - Contact:
      
      Ángel Luis Guerrero Peral
      
      Phone Number: (+34) 630981360
      
      Email: gueneurol@gmail.com
  - Valladolid, Spain, 47001
    - Recruiting
    - Hospital Clínico Universitario de Valladolid
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Active, not recruiting
    - Hospital Universitario Marqués de Valdecilla
Sweden
- - Lund, Sweden, 222 22
    - Recruiting
    - ProbarE i Lund
  - Stockholm, Sweden, 113 29
    - Recruiting
    - ProbarE i Stockholm AB
  - Örebro, Sweden, 70362
    - Active, not recruiting
    - Universitetssjukhuset Örebro
  - 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, WC1N 3JH
    - Recruiting
    - Great Ormond Street Hospital GOSH for Children NHS Foundation Trust - Headache Clinic
    - Contact:
      
      Prabhakar Prab
      
      Phone Number: 207 4059200
      
      Email: Prab.Prabhakar@gosh.nhs.uk
  - London, United Kingdom, W1G 9JF
    - Recruiting
    - Re:Cognition Health Limited
- Leics
  - Leicester, Leics, United Kingdom, LE5 4PW
    - Active, not recruiting
    - University Hospitals of Leicester - NHS Trust Research - Innovation Leicester General Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35244
    - Recruiting
    - Accel Research Sites-Neurology and Neurodiagnostics of Alabama, LLC
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Recruiting
    - Phoenix Children's Hospital
  - Scottsdale, Arizona, United States, 85254
    - Recruiting
    - Perseverance Research Center, LLC
  - Tempe, Arizona, United States, 85284
    - Recruiting
    - Physicians Research Group
    - Contact:
      
      Vianeth Santiago
      
      Phone Number: 480-454-5613
      
      Email: v.santiago@prgresearch.com
- California
  - Anaheim, California, United States, 92805
    - Recruiting
    - Advanced Research Center, Inc.
  - Banning, California, United States, 92220
    - Recruiting
    - Velocity Clinical Research, Banning
  - Culver City, California, United States, 90230
    - Recruiting
    - ProScience Research Group
    - Contact:
      
      Paola Aguirre
      
      Phone Number: 424-227-8127
      
      Email: hannah.lark@prosciencerg.com
  - Fresno, California, United States, 93710
    - Recruiting
    - Neuro-Pain Medical Center
  - La Jolla, California, United States, 92037
    - Recruiting
    - University of California, San Diego Altman Clinical Translational Research Institute
  - Lafayette, California, United States, 94549
    - Recruiting
    - Sunwise Clinical Research, LLC
  - Long Beach, California, United States, 90806
    - Recruiting
    - Miller Children's & Women's Hospital Long Beach
  - Los Angeles, California, United States, 90027
    - Not yet recruiting
    - Children's Hospital Los Angeles, Division of Neurology
  - Los Angeles, California, United States, 90027
    - Not yet recruiting
    - Children's Hospital Los Angeles-Children's Hospital Los Angeles Dept of Pharmacy
  - Los Angeles, California, United States, 90057
    - Active, not recruiting
    - National Research Institute
  - North Hollywood, California, United States, 91606
    - Recruiting
    - Velocity Clinical Research - North Hollywood
    - Contact:
      
      Erika Mendoza
      
      Phone Number: 818-558-7555
      
      Email: emendoza@velocityclinical.com
  - Pomona, California, United States, 91767
    - Recruiting
    - The Neurology Group
    - Contact:
      
      Ikram Rfifa
      
      Phone Number: 951-768-2352
      
      Email: Ikram@amctrials.com
  - Sacramento, California, United States, 95817
    - Recruiting
    - UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
  - Sacramento, California, United States, 95817
    - Not yet recruiting
    - University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
  - Sacramento, California, United States, 95816
    - Recruiting
    - University of California, Davis Midtown Clinic
  - Sacramento, California, United States, 95817
    - Recruiting
    - University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
  - Upland, California, United States, 91786
    - Recruiting
    - Pacific Clinical Research Management Group LLC
- 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
    - Recruiting
    - Colorado Springs Neurological Associates
    - Contact:
      
      Dominique Marshall
      
      Phone Number: 719-389-1113
      
      Email: dmarshall@csneuro.com
  - Grand Junction, Colorado, United States, 81501
    - Not yet recruiting
    - Boeson Research
  - Grand Junction, Colorado, United States, 81501
    - Not yet recruiting
    - Dinosaur Junction Pediatrics
  - Grand Junction, Colorado, United States, 81505
    - Not yet recruiting
    - Boeson Research - Grand Junction, CO
- Connecticut
  - Cromwell, Connecticut, United States, 06416
    - Not yet 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
    - Recruiting
    - Nemours Children's Health
  - Wilmington, Delaware, United States, 19803
    - Recruiting
    - Nemours Children's Hospital, Delaware
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Recruiting
    - Children's National Medical Center
- Florida
  - Apopka, Florida, United States, 32703
    - Recruiting
    - Topaz Clinical Research, Inc.
    - Contact:
      
      Marjorie Guzman
      
      Phone Number: 407-703-4342
      
      Email: Mguzman@topazclinicalresearch.com
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - First Choice Neurlogy Espinosa Neuroscience Institute
  - Cutler Bay, Florida, United States, 33157
    - Terminated
    - Beautiful Minds Clinical Research Center
  - DeLand, Florida, United States, 32720
    - Terminated
    - University Clinical Research - Deland, LLC dba Accel Research Sites
  - DeLand, Florida, United States, 32720
    - Terminated
    - Deland Clinical research Unit
  - Gainesville, Florida, United States, 32607
    - Recruiting
    - Sarkis Clinical Trials
    - Contact:
      
      Devin Vozza
      
      Phone Number: 352-333-0094
      
      Email: Devin@ehsfamily.com
  - Lake City, Florida, United States, 32055
    - 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, 33126
    - Recruiting
    - AppleMed Research Group, LLC
  - Miami, Florida, United States, 33176
    - Recruiting
    - Brainstorm Research
  - Miami, Florida, United States, 33176
    - Recruiting
    - The Neurology Research Group
    - Contact:
      
      Savannah Rodriguez
      
      Phone Number: 305-596-2080
      
      Email: srodriguez@fcneurology.net
  - Miami, Florida, United States, 33134
    - Active, not recruiting
    - Medical Research Center of Miami II, Inc
  - Miami, Florida, United States, 33165
    - Not yet recruiting
    - Genoma Research Group, Inc.
  - Miami Springs, Florida, United States, 33166
    - Not yet 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
  - Naples, Florida, United States, 34105
    - Recruiting
    - Collier Neurologic Specialists, LLC
  - Orange Park, Florida, United States, 32073
    - Recruiting
    - Coastal Clinical Research Specialists
    - Contact:
      
      Lew Whiting
      
      Phone Number: 904-303-3403
      
      Email: lwhiting@ccrsjax.com
  - Orlando, Florida, United States, 32806
    - Not yet recruiting
    - Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice
  - Orlando, Florida, United States, 32806
    - Not yet recruiting
    - Orlando Health Arnold Palmer Hospital for Children
  - Pembroke Pines, Florida, United States, 33026
    - Terminated
    - Bioresearch Institute
  - Tampa, Florida, United States, 33613
    - 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
    - Rare Disease Research, LLC
  - Atlanta, Georgia, United States, 30329
    - Recruiting
    - Children's Healthcare of Atlanta Center for Advanced Pediatrics
  - 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
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Riley Hospital for Children at IU Health
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Children's Clinical Research Center at Riley Hospital for Children at IU Health
  - Noblesville, Indiana, United States, 46060
    - Recruiting
    - Physicians Research Group
    - Contact:
      
      Maureen Banning
      
      Phone Number: 480-349-3412
      
      Email: m.banning@prgresearch.com
  - Westfield, Indiana, United States, 46074
    - Recruiting
    - Options Research Group, Llc
- Iowa
  - Sioux City, Iowa, United States, 51106
    - Recruiting
    - Meridian Clinical Research, LLC
    - Contact:
      
      Stephanie Pistore
      
      Phone Number: 712-639-6200
      
      Email: spistore@mcrmed.com
- Kansas
  - Overland Park, Kansas, United States, 66212
    - 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
    - Recruiting
    - Ochsner Clinic Foundation
    - Contact:
      
      Julie Schrader
      
      Phone Number: 504-703-9522
      
      Email: julie.schrader@ochsner.org
  - Shreveport, Louisiana, United States, 71105
    - Active, not recruiting
    - Neurology and Headache Center, Inc.
- Massachusetts
  - Boston, Massachusetts, United States, 02131
    - Recruiting
    - Boston Clinical Trials
    - Contact:
      
      Brianna Shaughnessy
      
      Phone Number: 617-477-4868
      
      Email: brianna@bostontrrials.com
  - Waltham, Massachusetts, United States, 02451
    - Recruiting
    - MedVadis Research Corporation
- Michigan
  - Ann Arbor, Michigan, United States, 48104
    - Recruiting
    - Michigan Head Pain & Neurological Institute
    - Contact:
      
      Stephanie Morley, RN
      
      Phone Number: 215 734-677-6000
      
      Email: smorley@mhni.com
  - Grand Rapids, Michigan, United States, 49503
    - Not yet recruiting
    - Spectrum Health Helen Devos Children's Hospital
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Outpatient Pediatric Neurology Clinic
  - 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
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Recruiting
    - Precise Research Centers
- Missouri
  - Ozark, Missouri, United States, 65721
    - Recruiting
    - Sharlin Health Neuroscience Research Center
    - Contact:
      
      Mikhayla Hamilton
      
      Phone Number: 417-485-4330
      
      Email: mikhayla@sharlinfxmed.com
  - Springfield, Missouri, United States, 65810
    - Recruiting
    - Clinvest Research, LLC
- Montana
  - Great Falls, Montana, United States, 59405
    - Recruiting
    - Boeson Research
  - Great Falls, Montana, United States, 59405
    - Recruiting
    - Northwest Physicians
  - Helena, Montana, United States, 59601
    - Recruiting
    - Boeson Research HLN
    - Contact:
      
      Ellie Bilyeu
      
      Phone Number: 406-763-8833
      
      Email: ellie@boesonresearch.com
  - Helena, Montana, United States, 59601
    - Recruiting
    - Helena Pediatric Clinic P.C.
  - Kalispell, Montana, United States, 59901
    - Recruiting
    - Boeson Research LLC
  - Missoula, Montana, United States, 59804
    - Recruiting
    - Boeson Research
  - Missoula, Montana, United States, 59804
    - Recruiting
    - Blue Moose Pediatrics
- Nebraska
  - Lincoln, Nebraska, United States, 68526
    - Terminated
    - Alivation Research, LLC.
  - Omaha, Nebraska, United States, 68114
    - Not yet recruiting
    - Children's Hospital & Medical Center
- New York
  - Amherst, New York, United States, 14226
    - Recruiting
    - Dent Neurosciences Research Center
  - Bronx, New York, United States, 10456
    - Terminated
    - Prime Global Research, LLC
  - Lake Success, New York, United States, 11042
    - Recruiting
    - Northwell Health/ Division of Pediatric Neurology
  - Mineola, New York, United States, 11501
    - Recruiting
    - NYU Langone Hospital-Long Island, Clinical Research Center
  - Mineola, New York, United States, 11501
    - Recruiting
    - NYU Langone Hospital-Long Island, Pediatric Neurology
  - New York, New York, United States, 10003
    - Recruiting
    - New York Neurology Associates
    - Contact:
      
      Shumaila Butt
      
      Phone Number: 908-812-4439
      
      Email: shumaila@nyneurologists.com
  - New York, New York, United States, 10032
    - Recruiting
    - The Neurological Institute of New York
  - New York, New York, United States, 10032
    - Recruiting
    - Columbia University Medical Center Research Pharmacy
  - New York, New York, United States, 10032
    - Recruiting
    - Columbia University Pediatric Neuromuscular Center
  - New York, New York, United States, 10032
    - Recruiting
    - Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
  - New York, New York, United States, 10029
    - Recruiting
    - Mount Sinai Hospital - Pharmacy Department
  - Port Jefferson Station, New York, United States, 11776
    - Recruiting
    - North Suffolk Neurology P.C
  - Rochester, New York, United States, 14618
    - Terminated
    - Finger Lakes Clinical Research
- North Carolina
  - Charlotte, North Carolina, United States, 28211
    - Recruiting
    - New Hope Clinical Research
    - Contact:
      
      Michael Adamson
      
      Phone Number: 980-209-9784
      
      Email: admason@newhcr.com
  - Greensboro, North Carolina, United States, 27405
    - Recruiting
    - Headache Wellness Center
    - Contact:
      
      Casey Wagner
      
      Phone Number: 336-574-8000
      
      Email: cwagner@headachewellnesscenter.com
  - Greensboro, North Carolina, United States, 27405
    - Recruiting
    - Headache Wellness Center, PC
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Atrium Health Wake Forest Baptist
- Ohio
  - Akron, Ohio, United States, 44308
    - Recruiting
    - Akron Children's Hospital
  - Cincinnati, Ohio, United States, 45229
    - Recruiting
    - Cincinnati Children's Hospital Medical Center
    - Contact:
      
      Jordyn Ng
      
      Phone Number: 513-803-5113
      
      Email: Jordyn.Ng@cchmc.org
    - Contact:
      
      Emily Hunsaker
      
      Phone Number: 513-803-5113
      
      Email: emily.hunsaker@cchmc.org
  - Cincinnati, Ohio, United States, 45242
    - Recruiting
    - Velocity Clinical Research
  - Cincinnati, Ohio, United States, 45229
    - Recruiting
    - Drug Delivery - Cincinnati Children's Hospital IDS - Denise Lagory
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - University Hospitals Cleveland Medical Center
  - Columbus, Ohio, United States, 43205
    - Recruiting
    - Nationwide Children's Hospital
  - Columbus, Ohio, United States, 43214
    - Recruiting
    - Wellnow Urgent Care and Research
    - Contact:
      
      Stephanie Scarberry
      
      Phone Number: 614-263-4401
      
      Email: Stephanie.Scarberry@wellnow.com
  - Columbus, Ohio, United States, 43228
    - 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
    - Recruiting
    - Velocity Clinical Research, Grants Pass
    - Contact:
      
      Melissa Myers
      
      Phone Number: 541-237-0323
      
      Email: mmyers@velocityclinical.com
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence Pediatric Neurology
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence Health & Services Investigational Drug Services Westside
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence Brain & Spine Institute-research coordinator's office
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Children's Hospital of Philadelphia
- Rhode Island
  - East Greenwich, Rhode Island, United States, 02818
    - Recruiting
    - Velocity Clinical Research-Providence
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - Recruiting
    - Meridian Clinical Research, LLC
    - Contact:
      
      Helen Myers
      
      Phone Number: 843-891-8670
      
      Email: hmyers@mcrmed.com
  - Greenville, South Carolina, United States, 29615
    - Recruiting
    - Velocity Clinical Research - Greenville
  - Greenville, South Carolina, United States, 29607
    - Recruiting
    - Tribe Clinical Research, LLC
  - Greenville, South Carolina, United States, 29605
    - Active, not recruiting
    - Premier Neurology, PC
  - North Charleston, South Carolina, United States, 29405
    - Recruiting
    - Coastal Carolina Research Center
    - Contact:
      
      Jade Clark
      
      Phone Number: 843-279-4610
      
      Email: jclark@coastalcarolinaresearch.com
- Tennessee
  - Kingsport, Tennessee, United States, 37660
    - Recruiting
    - Holston Medical Group
    - Contact:
      
      Ashley Helton
      
      Phone Number: 423-857-2787
      
      Email: ashley.helton@myhmg.com
  - Kingsport, Tennessee, United States, 37660
    - Active, not recruiting
    - Holston Medical Group
  - Kingsport, Tennessee, United States, 37660
    - Active, not recruiting
    - Holston Medical Group.
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Access Clinical Trials, Inc.
    - Contact:
      
      Diane Kolaski
      
      Phone Number: 615-320-6076
      
      Email: dkolaski@accessclintrials.com
- Texas
  - Austin, Texas, United States, 78723
    - Recruiting
    - Dell Children's Medical Center
  - Austin, Texas, United States, 78759
    - Recruiting
    - BioBehavioral Research of Austin
    - Contact:
      
      Julia Percy
      
      Phone Number: 512-382-6661
      
      Email: info@bbraustin.com
  - 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
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - Houston Clinical Trials, LLC
  - Dallas, Texas, United States, 75251
    - Recruiting
    - Cedar Health Research
    - Contact:
      
      Kate Collins
      
      Phone Number: 214-253-8170
      
      Email: Kate.Collins@CedarResearch.com
  - Dallas, Texas, United States, 75231
    - Recruiting
    - Future Search Trials of Dallas, LP
  - Dallas, Texas, United States, 75235
    - Recruiting
    - Children's Medical Center, Dallas
  - Dallas, Texas, United States, 75235
    - Recruiting
    - Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
  - El Paso, Texas, United States, 79912
    - Not yet recruiting
    - ANRC 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:
      
      Aishwarya Murthy
      
      Phone Number: 832-757-4058
      
      Email: research@4saimanagement.com
  - Houston, Texas, United States, 77094
    - Recruiting
    - NeuroCare Plus
  - Houston, Texas, United States, 77081
    - Active, not recruiting
    - Houston Clinical Research,LLC.
  - Plano, Texas, United States, 75093
    - Recruiting
    - AIM Trials, LLC
- Utah
  - Salt Lake City, Utah, United States, 84107
    - Recruiting
    - JBR Clinical Research
    - Contact:
      
      Jenny Hunt
      
      Phone Number: 801-261-2000
      
      Email: jhunt@jbrutah.com
  - Salt Lake City, Utah, United States, 84107
    - Recruiting
    - Wasatch Clinical Research , LLC(Administrative Location)
- Vermont
  - Burlington, Vermont, United States, 05401
    - Recruiting
    - The University of Vermont Medical Center
- Virginia
  - Charlottesville, Virginia, United States, 22902
    - Recruiting
    - Pediatric Research of Charlottesville, LLC
    - Contact:
      
      Christiana King
      
      Phone Number: 434-872-9384
      
      Email: christianaking@comcast.net
  - 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
  - Richmond, Virginia, United States, 23294
    - Recruiting
    - National Clinical Research, Inc.
- Washington
  - Bellevue, Washington, United States, 98007
    - Recruiting
    - Northwest Clinical Research Center
    - Contact:
      
      Lisa Matriccino
      
      Phone Number: 425-453-0404
      
      Email: lmatriccino@nwcrc.net
  - Everett, Washington, United States, 98201
    - Active, not recruiting
    - Eastside Therapeutic Resource, Inc. dba Core Clinical Research
  - Seattle, Washington, United States, 98105
    - Not yet recruiting
    - Seattle Children's Hospital
  - Seattle, Washington, United States, 98105
    - Not yet recruiting
    - Seattle Children's Hospital Investigational Drug Services
  - Seattle, Washington, United States, 98105
    - Not yet recruiting
    - Seattle Children's Investigational Drug Service
- Wisconsin
  - Kenosha, Wisconsin, United States, 53144
    - Recruiting
    - Clinical Investigation Specialists, Inc
  - Madison, Wisconsin, United States, 53705
    - Not yet recruiting
    - University Hospital
  - Madison, Wisconsin, United States, 53792
    - Not yet recruiting
    - University of Wisconsin-Madison
  - 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

Description

Inclusion Criteria:

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.
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.
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).

Exclusion Criteria:

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.
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

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

Number of Arms

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

To obtain contact information for a study center near you, click here.

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)

October 30, 2026

Study Completion (Estimated)

July 15, 2031

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)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

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))

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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

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Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Medical Conditions

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Conditions

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Drug Interventions

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Locations