Randomized Study in Children and Adolescents With Migraine: Acute Treatment
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
4 other identifiers
interventional
2,100
9 countries
246
Brief Summary
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2021
Longer than P75 for phase_3
246 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 9, 2029
July 29, 2026
July 1, 2026
8 years
November 23, 2020
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.
Pain freedom will be assessed in adolescent population (≥ 12 to \< 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
2 hours post-dose
Secondary Outcomes (16)
To compare rimegepant with placebo for pain freedom in children and adolescents combined.
2 hours post-dose
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
2 hours post-dose
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
Within 24 hours and 48 hours of initial treatment
To compare rimegepant with placebo on sustained pain freedom in adolescents.
2 to 24 hours post-dose
To compare rimegepant with placebo on sustained pain freedom in adolescents.
2 to 48 hours post-dose
- +11 more secondary outcomes
Study Arms (2)
BHV3000 (active drug)
ACTIVE COMPARATORBHV3000 (rimegepant) 75 mg or 50 mg ODT
Placebo
PLACEBO COMPARATORMatching 75 mg or 50 mg ODT placebo
Interventions
Eligibility Criteria
You may qualify if:
- History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours.
- Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.
- Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
- Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
- Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (246)
Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama
Birmingham, Alabama, 35244, United States
Perseverance Research Center, LLC
Scottsdale, Arizona, 85253, United States
Physicians Research Group
Tempe, Arizona, 85284, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
Adult & Child Neurology Medical Associates
Costa Mesa, California, 92627, United States
ProScience Research Group
Culver City, California, 90230, United States
Memorial Health Services
Fountain Valley, California, 92708, United States
Neuro-Pain Research Center
Fresno, California, 93710, United States
Altman Clinical and Translational Research Institute, University of California San Diego
La Jolla, California, 92037, United States
Adult & Child Neurology Medical Associates
Long Beach, California, 90806, United States
Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806, United States
National Research Institute
Los Angeles, California, 90057, United States
Velocity Clinical Research - North Hollywood
North Hollywood, California, 91606, United States
Children's Hospital of Orange County - Inpatient Pharmacy
Orange, California, 92868, United States
Children's Hospital of Orange County - Neuroscience Center
Orange, California, 92868, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
The Neurology Group
Pomona, California, 91767, United States
University of California, Davis Midtown Clinic
Sacramento, California, 95816, United States
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
Sacramento, California, 95817, United States
University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
Sacramento, California, 95817, United States
Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)
San Bernardino, California, 92408, United States
Pacific Clinical Research Management Group LLC
Upland, California, 91786, United States
Sunwise Clinical Research
Walnut Creek, California, 94596, United States
Children's Hospital Colorado- lnvestigational Drug Services
Aurora, Colorado, 80045, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, 80907, United States
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, 80919, United States
CT Clinical Research
Cromwell, Connecticut, 06416, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Topaz Clinical Research, Inc.
Apopka, Florida, 32703, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157, United States
DeLand Clinical Research Unit
DeLand, Florida, 32720, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
Watson Clinic Center for Research, Inc.
Lakeland, Florida, 33805, United States
Watson Clinic LLP
Lakeland, Florida, 33805, United States
AppleMed Research Group, LLC
Miami, Florida, 33126, United States
Medical Research Center of Miami II, Inc
Miami, Florida, 33134, United States
South Florida Research Phase I-IV, Inc
Miami, Florida, 33166, United States
Brainstorm Research
Miami, Florida, 33176, United States
Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office
Naples, Florida, 34102, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
Coastal Clinical Research Specialists
Orange Park, Florida, 32073, United States
Clinical Associates of Orlando, LLC
Orlando, Florida, 32819, United States
Bioresearch Institute
Pembroke Pines, Florida, 33026, United States
Forcare Clinical Research
Tampa, Florida, 33613, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta, Inc.
Atlanta, Georgia, 30329, United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Rare Disease Research, LLC
Atlanta, Georgia, 30329, United States
Pivotal Clinical Research & Associates, LLC
Brunswick, Georgia, 31520, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Chicago Headache Center & Research Institute
Chicago, Illinois, 60657, United States
AMR-Baber Research Inc
Naperville, Illinois, 60563, United States
Options Research Group, LLC
Westfield, Indiana, 46074, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106, United States
Integrated Clinical Trial Services
West Des Moines, Iowa, 50265, United States
Clinical Associates Midwest, LLC
Kansas City, Kansas, 66214, United States
College Park Family Care Center Physicians Group- Neurology Research Dept.
Overland Park, Kansas, 66212, United States
Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"
Lexington, Kentucky, 40504, United States
UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"
Lexington, Kentucky, 40536, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Neurology and Headache Center, Inc.
Shreveport, Louisiana, 71105, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
Grand Rapids, Michigan, 49503, United States
Corewell Health, Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Wellnow Urgent Care and Research
Kalamazoo, Michigan, 49048, United States
Beaumont Hospital Royal Oak Campus
Royal Oak, Michigan, 48073, United States
Brackenridge Outpatient Research Pharmacy
Rochester, Minnesota, 55905, United States
Clinical Research Trials Unit
Rochester, Minnesota, 55905, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Sharlin Health Neuroscience Research Center
Ozark, Missouri, 65721, United States
Clinvest Research, LLC
Springfield, Missouri, 65810, United States
Boeson Research
Great Falls, Montana, 59405, United States
Boeson Research
Kalispell, Montana, 59901, United States
Heart & Hands Midwifery
Kalispell, Montana, 59901, United States
Blue Moose Pediatrics
Missoula, Montana, 59804, United States
Boeson Research Laboratory
Missoula, Montana, 59804, United States
Boeson Research
Missoula, Montana, 59804, United States
Alivation Research, LLC.
Lincoln, Nebraska, 68526, United States
Children's Hospital & Medical Center
Omaha, Nebraska, 68114, United States
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
HOPE Tower at Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
True North Neurology
Commack, New York, 11725, United States
Northwell Health/ Division of Pediatric Neurology
Lake Success, New York, 11042, United States
NYU Langone Hospital-Long Island, Clinical Research Center
Mineola, New York, 11501, United States
NYU Langone Hospital-Long Island, Pediatric Neurology
Mineola, New York, 11501, United States
New York Neurology Associates
New York, New York, 10003, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Mount Sinai Hospital - Pharmacy Department
New York, New York, 10029, United States
Columbia University Medical Center Research Pharmacy
New York, New York, 10032, United States
Columbia University Pediatric Neuromuscular Center
New York, New York, 10032, United States
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
New York, New York, 10032, United States
The Neurological Institute of New York
New York, New York, 10032, United States
The Trustees of Columbia University and The New York and Presbyterian Hospital
New York, New York, 10032, United States
North Suffolk Neurology P.C
Port Jefferson Station, New York, 11776, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Prime Global Research, LLC
The Bronx, New York, 10456, United States
New Hope Clinical Research
Charlotte, North Carolina, 28211, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28277, United States
Velocity Clinical Research, Inc.
Durham, North Carolina, 27701, United States
Headache Wellness Center, PC
Greensboro, North Carolina, 27405, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Velocity Clinical Research
Cincinnati, Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Wellnow Urgent Care and Research
Columbus, Ohio, 43228, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720, United States
IPS Research Company
Oklahoma City, Oklahoma, 73106, United States
Lynn Institute of Tulsa
Tulsa, Oklahoma, 74135, United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527, United States
Providence Neuroscience Institute - Research Coordinator's Office
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Clario
Philadelphia, Pennsylvania, 19103, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818, United States
Premier Neurology, PC
Greenville, South Carolina, 29605, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Velocity Clinical Research - Greenville
Greenville, South Carolina, 29615, United States
Holston Medical Group.
Kingsport, Tennessee, 37660, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Le Bonheur Children's Hospital - Outpatient Building
Memphis, Tennessee, 38103, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
Memphis, Tennessee, 38103, United States
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
Child Neurology Consultants of Austin - South Austin
Austin, Texas, 78749, United States
Child Neurology Consultants of Austin - Central Austin
Austin, Texas, 78757, United States
BioBehavioral Research of Austin
Austin, Texas, 78759, United States
Houston Clinical Trials, LLC
Bellaire, Texas, 77401, United States
Infinite Research Group, LLC
Dallas, Texas, 75201, United States
Children's Medical Center, Dallas
Dallas, Texas, 75235, United States
Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)
Dallas, Texas, 75235, United States
Cedar Health Research
Dallas, Texas, 75251, United States
FutureSearch Trials of Dallas, LLC
Dallas, Texas, 75251, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
ANESC Research
El Paso, Texas, 79912, United States
North Texas Institute of Neurology and Headache
Frisco, Texas, 75034, United States
UTHealth Houston
Houston, Texas, 77030, United States
Pain and Headache Centers of Texas
Houston, Texas, 77054, United States
SCLA Management
Houston, Texas, 77077, United States
Houston Clinical Research,LLC.
Houston, Texas, 77081, United States
NeuroCare Plus
Houston, Texas, 77094, United States
AIM Trials, LLC
Plano, Texas, 75093, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
Wasatch Clinical Research , LLC(Administrative Location)
Salt Lake City, Utah, 84107, United States
The University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
Charlottesville, Virginia, 22902, United States
Pediatric Research of Charlottesville, LLC (Regulatory Only)
Charlottesville, Virginia, 22902, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
Children's Specialty Group, PLLC
Norfolk, Virginia, 23507, United States
Children's Specialty Group, PLLC, Division of Childhood & Adolescent Neurology
Norfolk, Virginia, 23510, United States
National Clinical Research, Inc.
Richmond, Virginia, 23294, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
Everett, Washington, 98201, United States
Seattle Children's Hospital Investigational Drug Services
Seattle, Washington, 98105, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Clinical Investigation Specialists, Inc
Kenosha, Wisconsin, 53144, United States
University Hospital
Madison, Wisconsin, 53792, United States
Kelowna Health & Memory Centre
Kelowna BC, British Columbia, V1Y 5A8, Canada
Diex Recherche Sherbrooke Inc
Sherbrooke, Quebec, J1L 0H8, Canada
First Affiliated Hospital of Bengbu Medical College Neurology
Bengbu, Anhui, 233000, China
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100089, China
" The First Affiliated Hospital of Chongqing Medical University"
Chongqing, Chongqing Municipality, 400042, China
Lanzhou university second hospital
Lanzhou, Gansu, 730030, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518034, China
Hainan General Hospital
Haikou, Hainan, 571140, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050004, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
Jingzhou First People's Hospital
Jingzhou, Hubei, 434000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Hunan Children's Hospital
Changsha, Hunan, 410007, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Wuxi Children's Hospital
Wuxi, Jiangsu, 214023, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214115, China
Xuzhou Children's Hospital
Xuzhou, Jiangsu, 221002, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
The First Hospital of Jilin University, Pediatric Neurology
Changchun, Jilin, 130021, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 756000, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Xi'an Gaoxin Hospital Neurology Department
Xi'an, Shaanxi, 710075, China
Yan 'an University Xianyang Hospital
Xianyang, Shaanxi, 716000, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250013, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, 315012, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Lu 'an People's Hospital
Lu'an, China
Children's Hospital of Shanghai
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of Shihezi University School of Medicine
Shihezi, China
Wuhan Children's Hospital
Wuhan, China
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816-0802, Japan
Ikeda Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816-0824, Japan
Hikita Pediatric Clinic
Kiryu-shi, Gunma, 3760035, Japan
Konan Medical Center
Higashinada-ku Kobe-shi, Hyōgo, 658-0064, Japan
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, 663-8204, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015, Japan
Tanaka Neurosurgery & Headache Clinic
Kagoshima, Kagoshima-ken, 890-0052, Japan
Sendai Headache and Neurology Clinic
Taihaku-ku Sendai-shi, Miyagi, 982-0014, Japan
Tennoji Dai Brain Clinic
Abeno-ku Osaka-shi, Osaka, 545-0053, Japan
Tominaga Clinic
Naniwa-ku, Osaka, 556-0015, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Local lndependent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City
Hiroshima, 730-8518, Japan
Clinstile S.A. de C.V.
Col. Roma Norte, Mexico City, C.P. 06700., Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, 800200, Mexico
Clinical Reseach Institute, S.C.
Tlalnepantla, State of Mexico, C.P. 54055, Mexico
Unidad de Investigacion en Salud de Chihuahua S.C.
Chihuahua City, 31203, Mexico
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
Katowice, 40-123, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Oddzial Kliniczny Dzieci Starszych z Pododdzialami: Neurologicznym, Reumatologicznym
Krakow, 31-503, Poland
Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, Apteka Szpitalna
Krakow, 31-503, Poland
Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
Krakow, 31-503, Poland
Clinical Research Center Sp. z.o.o. Medic-R Spolka komandytowa
Poznan, 61-731, Poland
Euromedis Sp. z o. o.
Szczecin, 70-111, Poland
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Centre d'Atencio Primaria Balenya
Barcelona, 08550, Spain
Instituto de Investigaciones del Sueno
Madrid, 28036, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47005, Spain
ProbarE i Lund AB
Lund, Skåne LÄN [se-12], 22222, Sweden
Avdelningen för kliniska Prövningar, Universitetssjukhuset Örebro
Örebro, 703 62, Sweden
ProbarE i Stockholm AB
Stockholm, 113 29, Sweden
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Re:Cognition Health Limited
London, W1G 9JF, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2020
First Posted
December 2, 2020
Study Start
January 15, 2021
Primary Completion (Estimated)
January 9, 2029
Study Completion (Estimated)
January 9, 2029
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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.