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NCT04965675PHASE3Recruiting

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

H. Lundbeck A/S

Start Date

6/30/2021

Completion Date

10/31/2026

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.

Detailed Description

The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.

Eligibility Criteria

Age Range: 12 years to 17 years

Inclusion Criteria: * The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit. * During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit. * During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary. Exclusion Criteria: * The participant has previously been randomised in this study and exposed to eptinezumab. * The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit. * The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit. * The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).

Interventions

DRUG

Eptinezumab

DRUG

Placebo

Interested in This Trial?

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Conditions

Chronic Migraine in Children

Locations

Yale-New Haven Children's Hospital - PIN

New Haven, Connecticut 06504-8901

United States

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut 06905-1206

United States

Children's National Medical Center

Washington D.C., District of Columbia 20010-2916

United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida 32561-4458

United States

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida 33012

United States

Axcess Medical Research

Loxahatchee Groves, Florida 33470-9272

United States

University of South Florida

Tampa, Florida 33612-6601

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

Baltimore, Maryland 21201

United States

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan 48104-5131

United States

Michigan State University - Department of Neurology

East Lansing, Michigan 48824-7015

United States

Corewell Health Butterworth Hospital

Grand Rapids, Michigan 49503-2560

United States

Dent Neurosciences Research Center Incorporated

Amherst, New York 14226-1746

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

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio 45229-3026

United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Road Runner Research Ltd

San Antonio, Texas 78249-3539

United States

Children's Specialty Group

Norfolk, Virginia 23510-1021

United States

Mary Bridge Children's Hospital - PIN

Tacoma, Washington 98405-4048

United States

Marshall University Medical Center

Huntington, West Virginia 25701-3656

United States

Hospital Privado de La Comunidad

Mar del Plata, Buenos Aires 7603

Argentina

Clínica Privada Independencia

Munro, Buenos Aires 1605

Argentina

Hospital Italiano de Buenos Aires

Ciudad Autónoma Buenos Aires, Buenos Aires F.D. C1181ACH

Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Ciudad Autónoma de BuenosAires C1280

Argentina

Sanatorio Allende S.A

Córdoba, Córdoba Province X5000JHGQ

Argentina

Hospital de Niños de La Santisima Trinidad

Córdoba-Barrio Crisol, 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 Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province T4000AXL

Argentina

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, C1128AAF

Argentina

University of Alberta

Edmonton, Alberta T6G 2R7

Canada

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

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Apulia 70124

Italy

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, Lazio 00165

Italy

IRCCS Istituto Giannina Gaslini

Genoa, Liguria 16147

Italy

Ospedale San Raffaele S.r.l.

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

Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.

Guadalajara, Jalisco 44700

Mexico

Unidad de Investigación en Salud de Chihuahua S.C.

Zapopan, Jalisco 45150

Mexico

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

Morelia, Michoacán 58260

Mexico

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

México, State of Mexico 14050

Mexico

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

Chihuahua City, 31000

Mexico

Neurociencias Estudios Clinicos S.C.

Culiacán Sinaloa, 80020

Mexico

Instituto de Investigationes Clinicas para la Salud A.C.

Durango, 34000

Mexico

Clinical Research Institute SC-Mexico

Tepetlacolco, 54055

Mexico

Centro de Estudios Clinicos Y Especialidades Medicas SC

Vista Hermosa, 64620

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 Almada-Seixal, EPE - Hospital Garcia de Orta

Almada, Setúbal District 2805-267

Portugal

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, 3000-602

Portugal

ULS de São João, EPE - Hospital de São João

Porto, 4200-319

Portugal

Childrens University Hospital

Belgrade, 11000

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

Children and Youth Health Care Institute of Vojvodina

Novi Sad, 21 000

Serbia

Clinical Centre of Vojvodina

Novi Sad, 21 000

Serbia

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra 36312

Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8025

Spain

Instituto del Sueño

Madrid, 28036

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013

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 Üniversitesi, Istanbul Tip Fakültesi, Nör

Fatih/Istanbul, 34093

Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih/Istanbul, 34096

Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, 33169

Turkey (Türkiye)

Royal Devon and Exeter Hospital NHS Trust - PPDS

Exeter, Devon EX2 5DW

United Kingdom

Great Ormond Street Hospital - PPDS

London, Greater London WC1N 3JH

United Kingdom

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

Queen Elizabeth University Hospital - PPDS

Glasgow, North Lanarkshire G51 4TF

United Kingdom