Clinical Trial for Pediatric Migraine.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Pediatric Migraine

Sex

Male or Female

Age

6 - 17 years

Healthy participants

Visit ClinicalTrials.gov for more information

Eligibility criteria

Inclusion criteria

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).
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.
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.
Verbally distinguish between migraine and other types of headaches.
Participants must have a weight > 40 kg at the Screening Visit.
Adequate venous access for blood sampling.
Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).

Exclusion criteria

History of cluster headache or hemiplegic migraine headache.
Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
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.
History of suicidal behavior or major psychiatric disorder.
Current diagnosis or history of substance abuse; positive drug test at Screening.
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.
Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
Current diagnosis of viral hepatitis or a history of liver disease.
Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

Study overview

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.

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Miles

0500

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69 sites found

" The First Affiliated Hospital of Chongqing Medical University"

Chongqing, Chongqing Municipality, China, 400042

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AIM Trials, LLC

Plano, Texas, United States, 75093

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AMR-Baber Research Inc

Naperville, Illinois, United States, 60563

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ANESC Research

El Paso, Texas, United States, 79912

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Adult & Child Neurology Medical Associates

Costa Mesa, California, United States, 92627

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Adult & Child Neurology Medical Associates

Long Beach, California, United States, 90806

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Advanced Research Center, Inc.

Anaheim, California, United States, 92805

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Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China, 214115

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Anhui Provincial Hospital

Hefei, Anhui, China, 230000

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Boeson Research Laboratory

Missoula, Montana, United States, 59804

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Brackenridge Outpatient Research Pharmacy

Rochester, Minnesota, United States, 55905

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CT Clinical Research

Cromwell, Connecticut, United States, 06416

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Centrum Medyczne Plejady

Krakow, Poland, 30-363

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Child Neurology Consultants of Austin - Central Austin

Austin, Texas, United States, 78757

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Children's Hospital Colorado- lnvestigational Drug Services

Aurora, Colorado, United States, 80045

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Children's Hospital of the King's Daughters

Norfolk, Virginia, United States, 23507

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Children's Medical Center, Dallas

Dallas, Texas, United States, 75235

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Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)

Dallas, Texas, United States, 75235

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Children's Specialty Group, PLLC

Norfolk, Virginia, United States, 23507

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100089

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Clinical Associates of Orlando, LLC

Orlando, Florida, United States, 32819

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Clinstile S.A. de C.V.

Col. Roma Norte, Mexico City, Mexico, C.P. 06700.

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Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group

Grand Rapids, Michigan, United States, 49503

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Dell Children's Medical Center

Austin, Texas, United States, 78723

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First Affiliated Hospital of Bengbu Medical College Neurology

Bengbu, Anhui, China, 233000

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Forcare Clinical Research

Tampa, Florida, United States, 33613

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China, 756000

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Hospital Universitario Virgen del Rocío

Seville, Spain, 41013

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Integrated Clinical Trial Services

West Des Moines, Iowa, United States, 50265

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Le Bonheur Children's Hospital

Memphis, Tennessee, United States, 38103

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Le Bonheur Children's Hospital - Outpatient Building

Memphis, Tennessee, United States, 38103

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Le Bonheur Childrens Hospital - Childrens Foundation Research Institute

Memphis, Tennessee, United States, 38103

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Le Bonheur Outpatient Pharmacy

Memphis, Tennessee, United States, 38105

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Liaocheng People's Hospital

Liaocheng, Shandong, China, 252000

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Local lndependent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City

Hiroshima, Japan, 730-8518

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MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship, Poland, 52-210

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Memorial Health Services

Fountain Valley, California, United States, 92708

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Miller Children's & Women's Hospital Long Beach

Long Beach, California, United States, 90806

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Mito Kyodo General Hospital

Mito, Ibaraki, Japan, 310-0015

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NeuroCare Plus

Houston, Texas, United States, 77094

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Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, Mexico, 800200

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Ningbo Women and Children's Hospital

Ningbo, Zhejiang, China, 315012

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Northwest Clinical Research Center

Bellevue, Washington, United States, 98007

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OCT Research ULC

Kelowna, British Columbia, Canada, V1Y 1Z9

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Pain and Headache Centers of Texas

Houston, Texas, United States, 77054

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Providence Neuroscience Institute - Research Coordinator's Office

Portland, Oregon, United States, 97225

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Re:Cognition Health Limited

London, United Kingdom, W1G 9JF

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China, 430060

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Seattle Children's Hospital

Seattle, Washington, United States, 98105

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Seattle Children's Hospital Investigational Drug Services

Seattle, Washington, United States, 98105

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Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China, 710068

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Shengjing Hospital of China Medical University

Shenyang, China

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Shenzhen Children's Hospital

Shenzhen, Guangdong, China, 518034

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South Florida Research Phase I-IV, Inc

Miami, Florida, United States, 33166

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Sunwise Clinical Research

Walnut Creek, California, United States, 94596

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The Second Xiangya Hospital of Central South University

Changsha, Hunan, China, 410000

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Tominaga Clinic

Naniwa-ku, Osaka, Japan, 556-0015

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UTHealth Houston

Houston, Texas, United States, 77030

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Velocity Clinical Research

Cincinnati, Ohio, United States, 45242

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Velocity Clinical Research, Inc.

Durham, North Carolina, United States, 27701

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Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location)

San Bernardino, California, United States, 92408

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Velocity Clinical Research, Sioux City

Sioux City, Iowa, United States, 51106

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Velocity Clinical Research-Providence

East Greenwich, Rhode Island, United States, 02818

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West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

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Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, Apteka Szpitalna

Krakow, Poland, 31-503

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Wuhan Children's Hospital

Wuhan, China

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Xuzhou Children's Hospital

Xuzhou, Jiangsu, China, 221002

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Yan 'an University Xianyang Hospital

Xianyang, Shaanxi, China, 716000

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Children's Hospital of Orange County - Inpatient Pharmacy

Orange, California, United States, 92868

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Join PfizerConnect

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

Join PfizerConnect

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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