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RECRUITING
NCT04965675
PHASE3

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

Sponsor: H. Lundbeck A/S

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

285

Start Date

2021-06-30

Completion Date

2026-10-31

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DRUG

Eptinezumab

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

DRUG

Placebo

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

Locations (83)

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

Sarkis Clinical Trials - Gainesville

Gainesville, Florida, 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

Loxahatchee Groves, Florida, United States

University of South Florida - 13330 USF Laurel Dr

Tampa, Florida, United States

Clinical Integrative Research Center of Atlanta (CIRCAtl)

Atlanta, Georgia, United States

University of Kentucky HealthCare (UKHC) Kentucky Clinic

Lexington, Kentucky, United States

University of Maryland-Marlene and Stewart Greenebaum Cancer Center

Baltimore, Maryland, United States

Michigan Head Pain and Neurological Institute

Ann Arbor, 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 (CSG)

Norfolk, Virginia, United States

Mary Bridge Children's Hospital - PIN

Tacoma, Washington, United States

Marshall Health-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

Sanatorio Allende S.A.

Córdoba, Cordoba, Argentina, Argentina

Hospital de Niños de La Santisima Trinidad

Córdoba-Barrio Crisol, 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

Hospital Italiano de Buenos Aires (HIBA) - Centro de Esclerosis Multiple Buenos Aires (CEMBA)

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires (HOB)

Buenos Aires, Argentina

University of Alberta Hospital (UAH)

Edmonton, Alberta, Canada

Medical Arts Health Research Group - Penticton - PPDS

Penticton, British Columbia, Canada

Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic

Victoria, British Columbia, Canada

The Kids Clinic

Ajax, Ontario, Canada

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, Canada

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, Apulia, Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Rome, Lazio, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, Lombardy, Italy

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

Cagliari, Sardinia, Italy

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, Tuscany, Italy

Istituto Giannina Gaslini IRCCS

Genoa, Italy

Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA)

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

Centro de Estudios Clinicos y Especialidades Medicas SC

Monterrey, New Leon, Mexico

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, Mexico

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

México, State of Mexico, Mexico

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

Chihuahua City, Mexico

Instituto de Investigationes Clinicas para la Salud A.C.

Durango, Mexico

Clinical Research Institute SC-Mexico

Tepetlacolco, Mexico

AthleticoMed Sp. z o.o.

Bydgoszcz, Kuyavian-Pomerania, 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

Unidade Local de Saúde de Almada-Seixal, E. P. E (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 Center of Vojvodina - Clinic of Psychiatry

Novi Sad, Serbia

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Madrid, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Pontevedra, Spain

Hospital Universitario Virgen del Rocio - PPDS

Sevilla, Valencia, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Izmir City Hospital

Bayraklı, İzmir, Turkey (Türkiye)

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Fatih/Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih/Istanbul, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Royal Devon and Exeter Hospital NHS Trust - PPDS

Exeter, Devon, 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

NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...

Glasgow, North Lanarkshire, United Kingdom

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom