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NCT05897320PHASE3Recruiting

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

H. Lundbeck A/S

Start Date

6/8/2023

Completion Date

8/31/2027

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 Criteria

Age Range: 6 years to 17 years

Inclusion Criteria: * Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit. * During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit. * During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary. Exclusion Criteria: * History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min). * History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system. * 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 are excluded. * Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance. Other inclusion and exclusion criteria may apply.

Interventions

DRUG

Eptinezumab

DRUG

Placebo

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Conditions

Episodic Migraine

Locations

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut 06905-1206

United States

Child Neurology of NW Florida

Gulf Breeze, Florida 32561-4495

United States

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida 33012

United States

University of South Florida - 13330 USF Laurel Dr

Tampa, Florida 33620

United States

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia 30328-6191

United States

University of Kentucky HealthCare (UKHC) Kentucky Clinic

Lexington, Kentucky 40508-1683

United States

University of Maryland School of Medicine

Baltimore, Maryland 21201-1544

United States

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan 48104-5131

United States

North Suffolk Neurology-Commack

Commack, New York 11725-2808

United States

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

Charlotte, North Carolina 28211-5027

United States

Childrens Hospital Medical Center of Akron

Akron, Ohio 44308-1063

United States

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio 45229-3026

United States

Road Runner Research Ltd

San Antonio, Texas 78249-3539

United States

Children's Specialty Group - 3 Commercial Place

Norfolk, Virginia 23510

United States

Childrens Hospital of Wisconsin - PIN

New Berlin, Wisconsin 53151-7494

United States

Clínica Privada Independencia

Munro, Buenos Aires 1605

Argentina

Hospital Britanico de Buenos Aires

Barracas, Ciudad Autónoma de BuenosAires C1280AEB

Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province 5800

Argentina

INECO Neurociencias Oroño

Rosario, Santa Fe Province S2000DTP

Argentina

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province T4000AXL

Argentina

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, C1128AAF

Argentina

Hospital de Niños de La Santisima Trinidad

Córdoba, X5000BNB

Argentina

Medical Arts Health Research Group - Penticton - PPDS

Penticton, British Columbia V2A 5L5

Canada

Vancouver Island Health Authority

Victoria, British Columbia V8R 1J8

Canada

The Kids Clinic

Ajax, Ontario L1Z 0M1

Canada

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario N6A 5W9

Canada

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, Lazio 00165

Italy

Istituto G Gaslini Ospedale Pediatrico IRCCS

Genoa, Liguria 16147

Italy

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy 20132

Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy 20133

Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy 27100

Italy

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

Cagliari, Sardinia 09121

Italy

Azienda Ospedaliero Universitaria A Meyer (Duplicate)

Florence, Tuscany 50139

Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany 56126

Italy

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

Morelia, Michoacán 58260

Mexico

Clinical Research Institute SC-Mexico

Tepetlacolco, 54055

Mexico

AthleticoMed

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-752

Poland

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

Krakow, Lesser Poland Voivodeship 30-363

Poland

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

Oświęcim, Lesser Poland Voivodeship 32-600

Poland

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship 52-210

Poland

ETG Lublin - PPDS

Lublin, Lublin Voivodeship 20-412

Poland

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship 02-172

Poland

ETG Neuroscience - PPDS

Warsaw, Masovian Voivodeship 02-677

Poland

ULS de São João, EPE - Hospital de São João

Porto Covo, Porto District 4200-319

Portugal

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto Covo, Setúbal District 4050-651

Portugal

Centro Clínico Académico, Braga - Hospital de Braga

Braga, 4710-243

Portugal

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, 3000-602

Portugal

Hospital CUF Descobertas

Lisbon, 1998-018

Portugal

Childrens University Hospital

Belgrade, 11000

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

University Clinical Center Nis

Niš, 18 000

Serbia

Children and Youth Health Care Institute of Vojvodina

Novi Sad, 21 000

Serbia

Clinical Centre of Vojvodina

Novi Sad, 21000

Serbia

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra 36312

Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8025

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026

Spain

Izmir City Hospital

Bayraklı, İzmir 35540

Turkey (Türkiye)

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, 26480

Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Fatih/Istanbul, 34093

Turkey (Türkiye)

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, 33169

Turkey (Türkiye)

Royal Hospital for Children and Young People - PIN

Edinburgh, Midlothian EH16 4TJ

United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk NR31 6LA

United Kingdom

Royal Hospital for Children (Glasgow) - PPDS - PIN

Glasgow, G514TF

United Kingdom

Great Ormond Street Hospital for Children

London, WCIN 3JH

United Kingdom