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

Last updated: March 19, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Eye Disease

Agoraphobia (Fear Of Crowds)

Communication Disorders

Treatment

Rimegepant (PF-07899801)

Rimegepant / BHV3000

Clinical Study ID

NCT04743141
BHV3000-312
C4951003
2020-003761-18
BHV3000-312
2024-512744-32-00
  • Ages 6-17
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 toscreening.

  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 atleast 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 musthave 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 reachtheir 18th birthday on or before the Baseline visit).

Exclusion

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 6months prior to the Screening Visit (lifetime history of psychosis and/or mania areexcluded).

  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 Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Rimegepant (PF-07899801)
Phase: 3
Study Start date:
April 28, 2021
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp. K.

    Poznań, Wielkopolska 61-731
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci

    Karkow, 31-503
    Poland

    Site Not Available

  • NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapis"

    Katowice, 40-123
    Poland

    Site Not Available

  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski

    Katowice, 40-123
    Poland

    Terminated

  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski

    Katowice 3096472, 40-123
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow, 30-363
    Poland

    Active - Recruiting

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci

    Krakow, 31-503
    Poland

    Active - Recruiting

  • Centrum Medyczne Plejady

    Krakow 3094802, 30-363
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci

    Krakow 3094802, 31-503
    Poland

    Active - Recruiting

  • Centrum Medyczne Plejady

    Kraków, 30-363
    Poland

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  • Clinical Research Center Sp. z o.o.

    Poznan, 60-848
    Poland

    Active - Recruiting

  • Clinical Research Center Sp. z o.o.

    Poznan 3088171, 60-848
    Poland

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  • Clinical Research Center Sp. z o.o.

    Poznań, 60-848
    Poland

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  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k

    Poznań, 61-731
    Poland

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    Szczecin, 70-111
    Poland

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    Szczecin,, 70-111,
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    Wroclaw, 52-416
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    Aurora, Colorado 80045
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    Grand Junction, Colorado 81505
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    Grand Junction, Colorado 81501
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    Grand Junction, Colorado 81501
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    Hartford, Connecticut 06106
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    Washington, District of Columbia 20003
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    Washington D.C., District of Columbia 20010
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  • Children's National Medical Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
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    Cutler Bay, Florida 33157
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    Lake City, Florida 32055
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    Miami, Florida 33126
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    Miami, Florida 33176
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    Orange Park, Florida 32073
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    Orlando, Florida 32819
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    Orlando, Florida 32806
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    Orlando, Florida 32806
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    South Miami, Florida 33155
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    Tampa, Florida 33613
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    West Palm Beach, Florida 33407
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    Atlanta, Georgia 30329
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    Atlanta, Georgia 30329
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    Atlanta, Georgia 30329
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    Brunswick, Georgia 31520
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    Decatur, Georgia 30030
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    Active - Recruiting

  • Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit

    New York, New York 10032
    United States

    Site Not Available

  • Mount Sinai Hospital - Pharmacy Department

    New York, New York 10029
    United States

    Site Not Available

  • New York Neurology Associates

    New York, New York 10003
    United States

    Active - Recruiting

  • The Neurological Institute of New York

    New York, New York 10032
    United States

    Site Not Available

  • North Suffolk Neurology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • Dent Neurosciences Research Center

    Amherst 5107129, New York 5128638 14226
    United States

    Site Not Available

  • True North Neurology

    Commack 5113412, New York 5128638 11725
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Columbia University Medical Center Research Pharmacy

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Columbia University Pediatric Neuromuscular Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Mount Sinai Hospital - Pharmacy Department

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • New York Neurology Associates

    New York 5128581, New York 5128638 10003
    United States

    Active - Recruiting

  • The Neurological Institute of New York

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • North Suffolk Neurology

    Port Jefferson Station 5132015, New York 5128638 11776
    United States

    Site Not Available

  • Mecklenburg Neurology Group

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina 28277
    United States

    Active - Recruiting

  • Headache Wellness Center

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • Headache Wellness Center, PC

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC

    Charlotte 4460243, North Carolina 4482348 28277
    United States

    Site Not Available

  • Headache Wellness Center, PC

    Greensboro 4469146, North Carolina 4482348 27405
    United States

    Site Not Available

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Drug Delivery-Cincinnati Children's IDS Denise Lagory

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • WellNow Urgent Care and Research

    Cincinnati, Ohio 45215
    United States

    Site Not Available

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Wellnow Urgent Care and Research

    Columbus, Ohio 43228
    United States

    Site Not Available

  • Wellnow Urgent Care and Research

    Dayton, Ohio 45424
    United States

    Site Not Available

  • Cincinnati Children's Hospital

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Active - Recruiting

  • Drug Delivery-Cincinnati Children's IDS Denise Lagory

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Active - Recruiting

  • Velocity Clinical Research - Cincinnati

    Cincinnati 4508722, Ohio 5165418 45242
    United States

    Active - Recruiting

  • WellNow Urgent Care and Research

    Cincinnati 4508722, Ohio 5165418 45215
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Wellnow Urgent Care and Research

    Dayton 4509884, Ohio 5165418 45424
    United States

    Site Not Available

  • IPS Research Company

    Oklahoma City, Oklahoma 73106
    United States

    Site Not Available

  • IPS Research Company

    Oklahoma City 4544349, Oklahoma 4544379 73106
    United States

    Site Not Available

  • Velocity Clinical Research, Grants Pass

    Grants Pass, Oregon 97527
    United States

    Site Not Available

  • Providence Brain & Spine Institute-research coordinator's office

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Providence Brain and Spine Institute

    Portland, Oregon 97225
    United States

    Site Not Available

  • Providence Health & Services Investigational Drug Services Westside

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Velocity Clinical Research, Grants Pass

    Grants Pass 5729080, Oregon 5744337 97527
    United States

    Site Not Available

  • Providence Brain & Spine Institute-research coordinator's office

    Portland 5746545, Oregon 5744337 97225
    United States

    Active - Recruiting

  • Providence Health & Services Investigational Drug Services Westside

    Portland 5746545, Oregon 5744337 97225
    United States

    Active - Recruiting

  • Providence St. Vincent Medical Center

    Portland 5746545, Oregon 5744337 97225
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clario

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Clario

    Philadelphia 4560349, Pennsylvania 6254927 19103
    United States

    Site Not Available

  • Velocity Clinical Research-Providence

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Velocity Clinical Research-Providence

    East Greenwich 5221875, Rhode Island 5224323 02818
    United States

    Site Not Available

  • Tribe Clinical Research LLC

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

  • Velocity Clinical Research- Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Premier Neurology

    Greer, South Carolina 29650
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Velocity Clinical Research- Greenville

    Greenville 4580543, South Carolina 4597040 29615
    United States

    Site Not Available

  • Premier Neurology

    Greer 4580599, South Carolina 4597040 29650
    United States

    Site Not Available

  • Novaceut Clinical Research

    Clarksville, Tennessee 37043
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • Le Bonheur Childrens Hospital - Childrens Foundation Research Institute

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • Le Bonheur Childrens Hospital - Outpatient Building

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • Access Clinical Trials, Inc.

    Nashville, Tennessee 37203
    United States

    Terminated

  • Novaceut Clinical Research

    Clarksville 4613868, Tennessee 4662168 37043
    United States

    Site Not Available

  • Le Bonheur Children's Hospital

    Memphis 4641239, Tennessee 4662168 38103
    United States

    Site Not Available

  • Le Bonheur Childrens Hospital - Childrens Foundation Research Institute

    Memphis 4641239, Tennessee 4662168 38103
    United States

    Active - Recruiting

  • Le Bonheur Childrens Hospital - Outpatient Building

    Memphis 4641239, Tennessee 4662168 38103
    United States

    Active - Recruiting

  • Access Clinical Trials, Inc.

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Child Neurology Consultants of Austin - Central Austin

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Child Neurology Consultants of Austin - Central Austin Office

    Austin, Texas 78757
    United States

    Site Not Available

  • Child Neurology Consultants of Austin - South Austin

    Austin, Texas 78749
    United States

    Active - Recruiting

  • Dell Children's Medical Center

    Austin, Texas 78723
    United States

    Active - Recruiting

  • Houston Clinical Trials, LLC

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Cedar Health Research

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Infinite Research Group, LLC

    Dallas, Texas 75201
    United States

    Active - Recruiting

  • ANESC Research

    El Paso, Texas 79912
    United States

    Active - Recruiting

  • ANRC Research

    El Paso, Texas 79912
    United States

    Site Not Available

  • North Texas Institute of Neurology and Headache

    Frisco, Texas 75034
    United States

    Site Not Available

  • Houston Clinical Research,LLC.

    Houston, Texas 77081
    United States

    Terminated

  • NeuroCare Plus

    Houston, Texas 77094
    United States

    Active - Recruiting

  • Pain and Headache Centers of Texas

    Houston, Texas 77054
    United States

    Active - Recruiting

  • SCLA Management

    Houston, Texas 77077
    United States

    Active - Recruiting

  • Trio Clinical Trials, LLC.

    Houston, Texas 77008
    United States

    Site Not Available

  • AIM Trials, LLC

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Child Neurology Consultants of Austin - Central Austin

    Austin 4671654, Texas 4736286 78757
    United States

    Active - Recruiting

  • Child Neurology Consultants of Austin - South Austin

    Austin 4671654, Texas 4736286 78749
    United States

    Site Not Available

  • Dell Children's Medical Center

    Austin 4671654, Texas 4736286 78723
    United States

    Active - Recruiting

  • Houston Clinical Trials, LLC

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Cedar Health Research

    Dallas 4684888, Texas 4736286 75251
    United States

    Active - Recruiting

  • Infinite Research Group, LLC

    Dallas 4684888, Texas 4736286 75201
    United States

    Site Not Available

  • ANESC Research

    El Paso 5520993, Texas 4736286 79912
    United States

    Site Not Available

  • ANRC Research

    El Paso 5520993, Texas 4736286 79912
    United States

    Active - Recruiting

  • North Texas Institute of Neurology and Headache

    Frisco 4692559, Texas 4736286 75034
    United States

    Site Not Available

  • Houston Clinical Research,LLC.

    Houston 4699066, Texas 4736286 77081
    United States

    Terminated

  • NeuroCare Plus

    Houston 4699066, Texas 4736286 77094
    United States

    Active - Recruiting

  • Pain and Headache Centers of Texas

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

  • SCLA Management

    Houston 4699066, Texas 4736286 77077
    United States

    Site Not Available

  • Trio Clinical Trials, LLC.

    Houston 4699066, Texas 4736286 77008
    United States

    Site Not Available

  • AIM Trials, LLC

    Plano 4719457, Texas 4736286 75093
    United States

    Site Not Available

  • JBR Clinical Research

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Wasatch Clinical Research , LLC(Administrative Location)

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • JBR Clinical Research

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Active - Recruiting

  • Wasatch Clinical Research , LLC(Administrative Location)

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Site Not Available

  • Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

    Charlottesville, Virginia 22902
    United States

    Active - Recruiting

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia 22902
    United States

    Active - Recruiting

  • Pediatric Research of Charlottesville, LLC (Regulatory Only)

    Charlottesville, Virginia 22902
    United States

    Active - Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology

    Norfolk, Virginia 23510
    United States

    Active - Recruiting

  • National Clinical Research, Inc.

    Richmond, Virginia 23294
    United States

    Terminated

  • Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

    Charlottesville 4752031, Virginia 6254928 22902
    United States

    Active - Recruiting

  • Pediatric Research of Charlottesville, LLC

    Charlottesville 4752031, Virginia 6254928 22902
    United States

    Active - Recruiting

  • Pediatric Research of Charlottesville, LLC (Regulatory Only)

    Charlottesville 4752031, Virginia 6254928 22902
    United States

    Site Not Available

  • Children's Hospital of The King's Daughters

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Site Not Available

  • Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology

    Norfolk 4776222, Virginia 6254928 23510
    United States

    Active - Recruiting

  • National Clinical Research, Inc.

    Richmond 4781708, Virginia 6254928 23294
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Eastside Therapeutic Resource, Inc. dba Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Seattle Children's Hospital Investigational Drug Services

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Northwest Clinical Research Center

    Bellevue 5786882, Washington 5815135 98007
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

  • Seattle Children's Hospital Investigational Drug Services

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

  • University Hospital

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • Marshfield Clinic-Marshfield Center

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • University Hospital

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

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