Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
3 other identifiers
interventional
600
3 countries
126
Brief Summary
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Longer than P75 for phase_3
126 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
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedStudy Start
First participant enrolled
April 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
April 16, 2026
April 1, 2026
9.3 years
February 4, 2021
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities
To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to \< 18 years of age).
58 weeks
Secondary Outcomes (1)
The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation
58 weeks
Study Arms (1)
Active
EXPERIMENTALrimegepant 75 mg, 50 mg or 35 mg ODT
Interventions
Eligibility Criteria
You may qualify if:
- History of migraine (with or without aura) for ≥ 6 months before Screening.
- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
- or more migraine days requiring treatment during the Observation Phase.
- Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
- Ability to distinguish between migraine and other types of headaches.
- Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg.
- Adequate venous access for blood sampling.
- Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
You may not qualify if:
- History of cluster headache or hemiplegic migraine headache.
- Confounding and clinically significant pain syndrome.
- Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
- History of suicidal behavior or at risk of self-harm/harm to others.
- History of major psychiatric disorder.
- Current diagnosis or history of substance abuse
- Reported current use of or tested positive at Screening for drugs of abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (126)
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
ProScience Research Group
Culver City, California, 90230, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Regents of the University of California (UC San Diego)
La Jolla, California, 92093, United States
Adult & Child Neurology Medical Associates
Long Beach, California, 90806, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806, United States
Velocity Clinical Research - North Hollywood
North Hollywood, California, 91606, United States
The Neurology Group
Pomona, California, 91767, 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 Center
Sacramento, California, 95817, United States
University of California, Davis Midtown Clinic
Sacramento, California, 95817, United States
Velocity Clinical Research- Banning
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- Investigational 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
Boeson Research GJT
Grand Junction, Colorado, 81501, United States
Dinosaur Pediatrics
Grand Junction, Colorado, 81501, United States
Boeson Research GJT
Grand Junction, Colorado, 81505, United States
CT Clinical Research
Cromwell, Connecticut, 06416, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, 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
Physicians Group Services, PA d/b/a Coastal Health Research
Orange Park, Florida, 32073, United States
Clinical Associates of Orlando, LLC
Orlando, Florida, 32819, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, 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
Integrated Clinical Trial Services
West Des Moines, Iowa, 50265, United States
Clinical Associates Midwest, LLC
Kansas City, Kansas, 66214, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Michigan Head Pain and 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
Sharlin Health Neuroscience Research Center
Ozark, Missouri, 65721, United States
Clinvest Research, LLC
Springfield, Missouri, 65807, United States
Boeson Research
Great Falls, Montana, 59405, 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
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
True North Neurology
Commack, New York, 11725, United States
New York Neurology Associates
New York, New York, 10003, United States
Mount Sinai Hospital - Pharmacy Department
New York, New York, 10029, United States
Columbia University Irving Medical 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
North Suffolk Neurology
Port Jefferson Station, New York, 11776, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28277, United States
Headache Wellness Center, PC
Greensboro, North Carolina, 27405, United States
WellNow Urgent Care and Research
Cincinnati, Ohio, 45215, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Wellnow Urgent Care and Research
Dayton, Ohio, 45424, United States
IPS Research Company
Oklahoma City, Oklahoma, 73106, United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527, United States
Providence Investigational Drug Service - Westside
Portland, Oregon, 97225, United States
Providence Neuroscience Institute: Research Coordinators' Office
Portland, Oregon, 97225, United States
Providence Pediatric Specialty Clinic
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
Velocity Clinical Research- Greenville
Greenville, South Carolina, 29615, United States
Premier Neurology
Greer, South Carolina, 29650, United States
Novaceut Clinical Research
Clarksville, Tennessee, 37043, 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
Le Bonheur Childrens Hospital - Outpatient Building
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
Houston Clinical Trials, LLC
Bellaire, Texas, 77401, United States
Infinite Research Group, LLC
Dallas, Texas, 75201, United States
Cedar Health Research
Dallas, Texas, 75251, United States
ANESC Research
El Paso, Texas, 79912, United States
North Texas Institute of Neurology and Headache
Frisco, Texas, 75034, United States
Trio Clinical Trials, LLC.
Houston, Texas, 77008, 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
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 , 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
Seattle Children's Hospital Investigational Drug Services
Seattle, Washington, 98105, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
University Hospital
Madison, Wisconsin, 53792, United States
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
Katowice, 40-123, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
Krakow, 31-503, Poland
Clinical Research Center Sp. z o.o.
Poznan, 60-848, Poland
Pracownia Badan Klinicznych SALUS
Wroclaw, 52-210, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Centre Atencio Primaria (CAP) Balenya
Balenya, Barcelona, 08550, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003, Spain
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 8, 2021
Study Start
April 28, 2021
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
July 31, 2030
Last Updated
April 16, 2026
Record last verified: 2026-04
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.