Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

May 19, 2026 updated by: Pfizer

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

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

  • Poland
      • Katowice, Poland, 40-123
        • Terminated
        • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
      • Krakow, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
        • Contact:
      • Krakow, Poland, 31-503
        • Recruiting
        • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
      • Poznan, Poland, 60-848
        • Recruiting
        • Clinical Research Center Sp. z o.o.
      • Wroclaw, Poland, 52-416
        • Active, not recruiting
        • Centrum Medyczne Oporow
      • Wroclaw, Poland, 52-210
        • Recruiting
        • Pracownia Badan Klinicznych Salus
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
    • Barcelona
      • Balenya, Barcelona, Spain, 08550
        • Active, not recruiting
        • Centre Atencio Primaria (CAP) Balenya
  • United States
    • 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.
        • Contact:
      • Culver City, California, United States, 90230
        • Active, not recruiting
        • Proscience Research Group
      • Fresno, California, United States, 93710
        • Recruiting
        • Neuro-Pain Research Center
      • La Jolla, California, United States, 92093
        • Recruiting
        • Regents of the University of California (UC San Diego)
      • Long Beach, California, United States, 90806
        • Recruiting
        • Memorialcare Miller Children's & Women's Hospital Long Beach
      • Long Beach, California, United States, 90806
        • Recruiting
        • Adult & Child Neurology Medical Associates
      • North Hollywood, California, United States, 91606
        • Active, not recruiting
        • Velocity Clinical Research - North Hollywood
      • 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, 95817
        • Active, not recruiting
        • University of California, Davis Clinical and Translational Science Center Clinical Research Center
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • University of California, Davis Midtown Clinic
      • San Bernardino, California, United States, 92408
        • Recruiting
        • Velocity Clinical Research- Banning
      • 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- Investigational 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
      • Grand Junction, Colorado, United States, 81501
        • Terminated
        • Boeson Research GJT
      • Grand Junction, Colorado, United States, 81501
        • Terminated
        • Dinosaur Pediatrics
      • Grand Junction, Colorado, United States, 81505
        • Terminated
        • Boeson Research GJT
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • Ki Health Partners, LLc, dba New England Institute for Clinical Research
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
    • Florida
      • 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
      • Orange Park, Florida, United States, 32073
        • Active, not recruiting
        • Physicians Group Services, PA d/b/a Coastal Health Research
      • Orlando, Florida, United States, 32819
      • 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
        • Active, not recruiting
        • Rare Disease Research LLC
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Childrens Healthcare of Atlanta
      • 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
      • West Des Moines, Iowa, United States, 50265
        • Recruiting
        • Integrated Clinical Trial Services
    • Kansas
      • Kansas City, Kansas, United States, 66214
        • Recruiting
        • Clinical Associates Midwest, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Terminated
        • Ochsner Clinic Foundation
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Active, not recruiting
        • MedVadis Research Corporation
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • Michigan Head Pain and Neurological Institute
      • 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
        • Terminated
        • Wellnow Urgent Care and Research
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Beaumont Hospital, Royal Oak Campus
    • Missouri
      • Ozark, Missouri, United States, 65721
        • Active, not recruiting
        • Sharlin Health Neuroscience Research Center
      • Springfield, Missouri, United States, 65807
        • 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
      • 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
        • Not yet recruiting
        • HMH Jersey Shore University Medical Center
      • Neptune City, New Jersey, United States, 07753
        • Not yet recruiting
        • Hope Tower
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurosciences Research Center
      • Commack, New York, United States, 11725
        • Recruiting
        • True North Neurology
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University Irving Medical Center
      • 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
        • 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
      • Port Jefferson Station, New York, United States, 11776
        • Active, not recruiting
        • North Suffolk Neurology
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Onsite Clinical Solutions, LLC
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Headache Wellness Center, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Velocity Clinical Research - Cincinnati
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
      • Cincinnati, Ohio, United States, 45215
        • Active, not recruiting
        • Wellnow Urgent Care and Research
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
      • Dayton, Ohio, United States, 45424
        • Active, not recruiting
        • Wellnow Urgent Care and Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Active, not recruiting
        • IPS Research Company
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Active, not recruiting
        • Velocity Clinical Research, Grants Pass
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Neuroscience Institute: Research Coordinators' Office
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Pediatric Specialty Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19103
        • Active, not recruiting
        • Clario
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research-Providence
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Active, not recruiting
        • Velocity Clinical Research- Greenville
      • Greer, South Carolina, United States, 29650
        • Active, not recruiting
        • Premier Neurology
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Active, not recruiting
        • Novaceut Clinical Research
      • 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 Childrens Hospital - Outpatient Building
      • Nashville, Tennessee, United States, 37203
        • Terminated
        • 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
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Houston Clinical Trials, LLC
      • Dallas, Texas, United States, 75251
        • Active, not recruiting
        • Cedar Health Research
      • Dallas, Texas, United States, 75201
        • Active, not recruiting
        • Infinite Research Group, LLC
      • 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, 77008
        • Active, not recruiting
        • Trio Clinical Trials, LLC.
      • Houston, Texas, United States, 77081
        • Terminated
        • 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)
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Recruiting
        • Pediatric Research of Charlottesville, LLC
      • 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
        • Terminated
        • National Clinical Research, Inc.
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital Investigational Drug Services
    • Wisconsin
      • 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 18 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. History of migraine (with or without aura) for ≥ 6 months before Screening.
  2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
  3. 1 or more migraine days requiring treatment during the Observation Phase.
  4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
  5. Ability to distinguish between migraine and other types of headaches.
  6. Weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25kg.
  7. Adequate venous access for blood sampling.
  8. Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and clinically significant pain syndrome.
  3. 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).
  4. History of suicidal behavior or at risk of self-harm/harm to others.
  5. History of major psychiatric disorder.
  6. Current diagnosis or history of substance abuse
  7. Reported current use of or tested positive at Screening for drugs of abuse.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
rimegepant 75 mg, 50 mg or 35 mg ODT
Drug: Rimegepant (PF-07899801)
Rimegepant 75 mg, 50 mg or 35 mg ODT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities
Time Frame: 58 weeks
To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to < 18 years of age).
58 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation
Time Frame: 58 weeks
To evaluate the frequency and severity of hepatic-related adverse events and the frequency of hepatic-related treatment discontinuations in children and adolescents (6 to less than 18 years of age) treated with rimegepant.
58 weeks

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)

April 28, 2021

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV3000-312 (Alias Study Number)
  • C4951003 (Other Identifier: Alias Study Number)
  • 2024-512744-32-00 (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.

Clinical Trials on Acute Treatment of Migraine

Clinical Trials on Rimegepant (PF-07899801)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe