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NCT04743141PHASE3Recruiting

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

Pfizer

Start Date

4/28/2021

Completion Date

7/31/2030

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

Age Range: 6 years to 17 years

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.

Interventions

DRUG

Rimegepant (PF-07899801)

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Conditions

Acute Treatment of Migraine

Locations

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 Research Center

Fresno, California 93710

United States

Altman Clinical and Translational Research Institute, University of California San Diego

La Jolla, California 93037

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

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, Inc.

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

Hope Tower

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 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 37103

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 Clinico Universitario de Valladolid

Valladolid, 47003

Spain