RecruitingPhase 3NCT04965675

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

Sponsor

H. Lundbeck A/S

Enrollment

285 participants

Start Date

Jun 30, 2021

Study Type

INTERVENTIONAL

Conditions

Chronic Migraine in Children

Summary

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests eptinezumab — an injectable medication given every 12 weeks — for preventing chronic migraine in adolescents aged 12–17. Eptinezumab targets CGRP, a protein involved in triggering migraines. You may be eligible if: - You are between 12 and 17 years old - You have a history of chronic migraine (with or without aura) for at least 6 months - During a 28-day screening period, you had 15–26 headache days and at least 8 migraine days - You reliably recorded your headaches in a diary for at least 23 of the 28 screening days You may NOT be eligible if: - You have previously received eptinezumab in this study - You have received any monoclonal antibody or CGRP antibody treatment in the last 6 months - You have been diagnosed with complicated migraine types such as hemiplegic migraine, cluster headache, or migraine with brainstem aura Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEptinezumab

Eptinezumab will be administered per dose and schedule specified in the arm.

DRUGPlacebo

Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Locations(84)

Yale-New Haven Children's Hospital - PIN

New Haven, Connecticut, United States

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida, United States

Axcess Medical Research

Loxahatchee Groves, Florida, United States

University of South Florida

Tampa, Florida, United States

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, United States

University of Kentucky HealthCare (UKHC) Kentucky Clinic

Lexington, Kentucky, United States

University of Maryland

Baltimore, Maryland, United States

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States

Michigan State University - Department of Neurology

East Lansing, Michigan, United States

Corewell Health Butterworth Hospital

Grand Rapids, Michigan, United States

Dent Neurosciences Research Center Incorporated

Amherst, New York, United States

North Suffolk Neurology-Commack

Commack, New York, United States

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

Charlotte, North Carolina, United States

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Road Runner Research Ltd

San Antonio, Texas, United States

Children's Specialty Group

Norfolk, Virginia, United States

Mary Bridge Children's Hospital - PIN

Tacoma, Washington, United States

Marshall University Medical Center

Huntington, West Virginia, United States

Hospital Privado de La Comunidad

Mar del Plata, Buenos Aires, Argentina

Clínica Privada Independencia

Munro, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autónoma Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Sanatorio Allende S.A

Córdoba, Córdoba Province, Argentina

Hospital de Niños de La Santisima Trinidad

Córdoba, Córdoba Province, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Argentina

University of Alberta

Edmonton, Alberta, Canada

Medical Arts Health Research Group - Penticton - PPDS

Penticton, British Columbia, Canada

Vancouver Island Health Authority

Victoria, British Columbia, Canada

The Kids Clinic

Ajax, Ontario, Canada

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, Canada

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Apulia, Italy

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, Lazio, Italy

IRCCS Istituto Giannina Gaslini

Genoa, Liguria, Italy

Ospedale San Raffaele S.r.l.

Milan, Lombardy, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, Italy

AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza

Cagliari, Sardinia, Italy

Azienda Ospedaliero Universitaria A Meyer (Duplicate)

Florence, Tuscany, Italy

Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.

Guadalajara, Jalisco, Mexico

Unidad de Investigación en Salud de Chihuahua S.C.

Zapopan, Jalisco, Mexico

Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia

Morelia, Michoacán, Mexico

ICARO Investigaciones en Medicina, S.A de C.V

Chihuahua City, Mexico

Neurociencias Estudios Clinicos S.C.

Culiacán Sinaloa, Mexico

Instituto de Investigationes Clinicas para la Salud A.C.

Durango, Mexico

Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city

Mexico City, Mexico

Clinical Research Institute SC-Mexico

México, Mexico

Centro de Estudios Clinicos Y Especialidades Medicas SC

Monterrey, Mexico

AthleticoMed

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa

Krakow, Lesser Poland Voivodeship, Poland

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

Oświęcim, Lesser Poland Voivodeship, Poland

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship, Poland

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, Poland

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland

ETG Neuroscience - PPDS

Warsaw, Masovian Voivodeship, Poland

ULS de Almada-Seixal, EPE - Hospital Garcia de Orta

Almada, Setúbal District, Portugal

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, Portugal

ULS de São João, EPE - Hospital de São João

Porto, Portugal

Childrens University Hospital

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Children and Youth Health Care Institute of Vojvodina

Novi Sad, Serbia

Clinical Centre of Vojvodina

Novi Sad, Serbia

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Instituto del Sueño

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, Turkey (Türkiye)

Istanbul Üniversitesi, Istanbul Tip Fakültesi, Nör

Fatih/Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih/Istanbul, Turkey (Türkiye)

Izmir City Hospital

Izmir, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Royal Devon and Exeter Hospital NHS Trust - PPDS

Exeter, Devon, United Kingdom

Queen Elizabeth University Hospital - PPDS

Glasgow, Lanarkshire, United Kingdom

Great Ormond Street Hospital - PPDS

London, London, City of, United Kingdom

Royal Hospital for Children and Young People - PIN

Edinburgh, Midlothian, United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04965675