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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

New England Institute for Clinical Research (NEICR) - Stamford

Stamford, Connecticut 06905-1206

United States

Child Neurology Center (CNC) of Northwest Florida

Gulf Breeze, Florida 32561-4458

United States

AGA Clinical Trials

Hialeah, Florida 33012-3407

United States

University of South Florida (USF) - Tampa Campus

Tampa, Florida 33620

United States

Clinical Integrative Research Center of Atlanta (CIRCAtl)

Atlanta, Georgia 30328-5574

United States

UK HealthCare-Kentucky Clinic

Lexington, Kentucky 40536

United States

University of Maryland School of Medicine

Baltimore, Maryland 21201-1509

United States

Michigan Headache & Neurological Institute (MHNI)

Ann Arbor, Michigan 48104-5131

United States

True North Neurology - Commack (North Suffolk Neurology)

Commack, New York 11725-2850

United States

OnSite Clinical Solutions, LLC - Charlotte

Charlotte, North Carolina 28210-0106

United States

Akron Children's Hospital

Akron, Ohio 44308-1062

United States

Cincinnati Children's Hospital Medical Center-Burnet Campus

Cincinnati, Ohio 45229-3026

United States

Road Runner Research (RRR)

San Antonio, Texas 78249-3539

United States

Children's Specialty Group (CSG)

Norfolk, Virginia 23507

United States

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

Milwaukee, Wisconsin 53226

United States

Hospital de Niños de la Santísima Trinidad

Córdoba, Córdoba Province X5014AKM

Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province 5800

Argentina

INECO Neurociencias Oroño

Rosario, Santa Fe Province S2000DTP

Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province T4000AXL

Argentina

Clinica Independencia

Buenos Aires, 1605

Argentina

Mautalen Salud e Investigacion

Buenos Aires, C1128AAF

Argentina

Hospital Britanico de Buenos Aires (HOB)

Buenos Aires, C1280AEB

Argentina

The Medical Arts Health Research Group - Penticton

Penticton, British Columbia V2A 5C8

Canada

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

Victoria, British Columbia V8R 1J8

Canada

Kids Clinic

Ajax, Ontario L1Z 0M1

Canada

London Health Sciences Centre (LHSC)

London, Ontario N6A 5W9

Canada

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

Cagliari, South Sardinia 09121

Italy

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

Genoa, 16147

Italy

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

Milan, 20133

Italy

Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

Pavia, 27100

Italy

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

Pisa, 56126

Italy

Ospedale Pediatrico Bambino Gesu - Gianicolo

Rome, 00165

Italy

Centro de Investigacion Clinica de Morelia, S.C.

Morelia, Michoacán 58070

Mexico

Clinical Research Institute SC-Mexico

Tepetlacolco, 54055

Mexico

AthleticoMed Sp. z o.o.

Bydgoszcz, Kuyavian-Pomerania 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

ETG Lublin

Lublin, Lublin Voivodeship 20-412

Poland

MTZ Clinical Research Powered by PRATIA

Warsaw, Masovian Voivodeship 02-172

Poland

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

Warsaw, Masovian Voivodeship 02-677

Poland

Hospital de Braga

Braga, 4710-367

Portugal

Hospital Pediátrico de Coimbra

Coimbra, 3000-602

Portugal

Hospital CUF Descobertas, S.A.

Lisbon, 1998-018

Portugal

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

Porto, 4050

Portugal

Centro Hospitalar Universitario de Sao Joao (CHUSJ)

Porto, 4200-319

Portugal

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

Belgrade, Beograd 11000

Serbia

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

Novi Sad, Juznobacki Okrug 21000

Serbia

Institute of Child and Youth Health Care of Vojvodina

Novi Sad, Juznobacki Okrug 21101

Serbia

Clinical Center Kragujevac

Kragujevac, Sumadijski Okrug 34000

Serbia

University Clinical Center Nis

Niš, 18 000

Serbia

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

Vigo, Pontevedra 36312

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

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

Valencia, 46026

Spain

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

Eskişehir, 26480

Turkey (Türkiye)

Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi

Istanbul, 34093

Turkey (Türkiye)

Izmir Şehir Hastanesi

Izmir, 35540

Turkey (Türkiye)

Mersin Universitesi-Tip Fakultesi

Mersin, 33343

Turkey (Türkiye)

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

Edinburgh, Eastern Scotland EH16 4TJ

United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk NR31 6LA

United Kingdom

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

Glasgow, South Western Scotland G51 4TF

United Kingdom

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3JH

United Kingdom