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RECRUITING
NCT05897320
PHASE3

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Sponsor: H. Lundbeck A/S

View on ClinicalTrials.gov

Summary

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

315

Start Date

2023-06-08

Completion Date

2027-08-31

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Eptinezumab

Solution for infusion

DRUG

Placebo

Solution for infusion

Locations (62)

New England Institute for Clinical Research (NEICR) - Stamford

Stamford, Connecticut, United States

Child Neurology Center (CNC) of Northwest Florida

Gulf Breeze, Florida, United States

AGA Clinical Trials

Hialeah, Florida, United States

University of South Florida (USF) - Tampa Campus

Tampa, Florida, United States

Clinical Integrative Research Center of Atlanta (CIRCAtl)

Atlanta, Georgia, United States

UK HealthCare-Kentucky Clinic

Lexington, Kentucky, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Michigan Headache & Neurological Institute (MHNI)

Ann Arbor, Michigan, United States

True North Neurology - Commack (North Suffolk Neurology)

Commack, New York, United States

OnSite Clinical Solutions, LLC - Charlotte

Charlotte, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center-Burnet Campus

Cincinnati, Ohio, United States

Road Runner Research (RRR)

San Antonio, Texas, United States

Children's Specialty Group (CSG)

Norfolk, Virginia, United States

Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus

Milwaukee, Wisconsin, United States

Hospital de Niños de la Santísima 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 Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Clinica Independencia

Buenos Aires, Argentina

Mautalen Salud e Investigacion

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires (HOB)

Buenos Aires, Argentina

The Medical Arts Health Research Group - Penticton

Penticton, British Columbia, Canada

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

Victoria, British Columbia, Canada

Kids Clinic

Ajax, Ontario, Canada

London Health Sciences Centre (LHSC)

London, Ontario, Canada

L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...

Cagliari, South Sardinia, Italy

Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare

Genoa, Italy

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Milan, Italy

Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

Pavia, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To...

Pisa, Italy

Ospedale Pediatrico Bambino Gesu - Gianicolo

Rome, Italy

Centro de Investigacion Clinica de Morelia, S.C.

Morelia, Michoacán, 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

ETG Lublin

Lublin, Lublin Voivodeship, Poland

MTZ Clinical Research Powered by PRATIA

Warsaw, Masovian Voivodeship, Poland

European Trial group network Sp. z o.o - Neuroscience

Warsaw, Masovian Voivodeship, Poland

Hospital de Braga

Braga, Portugal

Hospital Pediátrico de Coimbra

Coimbra, Portugal

Hospital CUF Descobertas, S.A.

Lisbon, Portugal

Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)

Porto, Portugal

Centro Hospitalar Universitario de Sao Joao (CHUSJ)

Porto, Portugal

Univerzitetska Decija Klinika (UDK) (University Children's Hospital)

Belgrade, Beograd, Serbia

University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic

Novi Sad, Juznobacki Okrug, Serbia

Institute of Child and Youth Health Care of Vojvodina

Novi Sad, Juznobacki Okrug, Serbia

Clinical Center Kragujevac

Kragujevac, Sumadijski Okrug, Serbia

University Clinical Center Nis

Niš, Serbia

Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC)

Vigo, Pontevedra, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, Spain

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)

Eskişehir, Turkey (Türkiye)

Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi

Istanbul, Turkey (Türkiye)

Izmir Şehir Hastanesi

Izmir, Turkey (Türkiye)

Mersin Universitesi-Tip Fakultesi

Mersin, Turkey (Türkiye)

NHS Lothian - Royal Hospital for Children & Young People (RHCYP)

Edinburgh, Eastern Scotland, United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, United Kingdom

NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...

Glasgow, South Western Scotland, United Kingdom

Great Ormond Street Hospital for Children NHS Foundation Trust

London, United Kingdom