RecruitingPhase 3NCT05897320

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

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

Sponsor

H. Lundbeck A/S

Enrollment

315 participants

Start Date

Jun 8, 2023

Study Type

INTERVENTIONAL

Conditions

Episodic Migraine

Summary

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

Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Eptinezumab and a drug called Placebo for people with episodic migraine. The study is currently recruiting participants at 65 locations. People eligible for this study include aged 6 Years to 17 Years.

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

Solution for infusion

DRUGPlacebo

Solution for infusion

Locations(65)

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, United States

Child Neurology of NW Florida

Gulf Breeze, Florida, United States

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida, United States

University of South Florida - 13330 USF Laurel Dr

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 School of Medicine

Baltimore, Maryland, United States

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States

North Suffolk Neurology-Commack

Commack, New York, United States

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

Charlotte, North Carolina, United States

Childrens Hospital Medical Center of Akron

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio, United States

Road Runner Research Ltd

San Antonio, Texas, United States

Children's Specialty Group - 3 Commercial Place

Norfolk, Virginia, United States

Childrens Hospital of Wisconsin - PIN

New Berlin, Wisconsin, United States

Clínica Privada Independencia

Munro, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Barracas, Ciudad Autónoma de BuenosAires, 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 de Niños de La Santisima Trinidad

Córdoba, Argentina

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

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, Lazio, Italy

Istituto G Gaslini Ospedale Pediatrico IRCCS

Genoa, Liguria, Italy

Ospedale San Raffaele S.r.l. - PPDS

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

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany, Italy

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

Morelia, Michoacán, Mexico

Clinical Research Institute SC-Mexico

Tepetlacolco, 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 São João, EPE - Hospital de São João

Porto Covo, Porto District, Portugal

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto Covo, Setúbal District, Portugal

Centro Clínico Académico, Braga - Hospital de Braga

Braga, Portugal

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, Portugal

Hospital CUF Descobertas

Lisbon, Portugal

Childrens University Hospital

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

University Clinical Center Nis

Niš, 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

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 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)

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, Turkey (Türkiye)

Royal Hospital for Children and Young People - PIN

Edinburgh, Midlothian, United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, United Kingdom

Royal Hospital for Children (Glasgow) - PPDS - PIN

Glasgow, United Kingdom

Great Ormond Street Hospital for Children

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05897320

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