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NCT04649242PHASE3Recruiting

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Pfizer

Start Date

1/15/2021

Completion Date

1/9/2029

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.

Eligibility Criteria

Age Range: 6 years to 17 years

Inclusion Criteria: 1. 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). 2. 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. 3. 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. 1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases. 2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited. 3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit. 4. Verbally distinguish between migraine and other types of headaches. 5. Participants must have a weight \> 40 kg at the Screening Visit. 6. Adequate venous access for blood sampling. 7. Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study). Exclusion Criteria: 1. History of cluster headache or hemiplegic migraine headache. 2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study. 3. 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. 4. History of suicidal behavior or major psychiatric disorder. 5. Current diagnosis or history of substance abuse; positive drug test at Screening. 6. 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. 7. Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit. 8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding). 9. Current diagnosis of viral hepatitis or a history of liver disease. 10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Interventions

DRUG

Rimegepant/BHV3000

DRUG

Matching placebo

Interested in This Trial?

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Conditions

Pediatric Migraine

Locations

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