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NCT05164172PHASE3Recruiting

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

H. Lundbeck A/S

Start Date

12/1/2021

Completion Date

4/30/2028

Summary

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

Detailed Description

This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine \[CM\] study in adolescents) or 19357A (episodic migraine \[EM\] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.

Eligibility Criteria

Age Range: 6 years to 17 years

Inclusion Criteria: \- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study. Exclusion Criteria: * The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator. * During lead-in Study19356A or Study19357A: * participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator * the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later. * the participant had a serum ALT or AST value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.

Interventions

DRUG

Eptinezumab

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Conditions

Migraine

Locations

Yale University School of Medicine

New Haven, Connecticut 06511

United States

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut 06905-1206

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

University of Kentucky

Lexington, Kentucky 40536-7001

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

Michigan State University - Department of Neurology

East Lansing, Michigan 48824-7015

United States

Helen Devos Childrens' Hospital - PIN

Grand Rapids, Michigan 49503-2528

United States

Dent Neurosciences Research Center Incorporated

Amherst, New York 14226-1727

United States

True North Neurology

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

Marshall University Medical Center

Huntington, West Virginia 25701-3656

United States

Children's Wisconsin - Milwaukee Campus - PIN

Milwaukee, Wisconsin 53226

United States

Hospital Privado de La Comunidad

Mar del Plata, Buenos Aires 7603

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

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

IRCCS Ospedale Pediatrico Bambino Gesu

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

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

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, 27100

Italy

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

Guadalajara, Jalisco 44700

Mexico

Clinical Research Institute SC-Mexico

Ampl San Lucas Tepetlacalco, State of Mexico 54055

Mexico

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

Chihuahua City, 31000

Mexico

Instituto de Investigationes Clinicas para la Salud A.C.

Durango, 34000

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 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

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

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, 21 000

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 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)

Mersin University Medical Faculty

Mersin, 33169

Turkey (Türkiye)

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, G514TF

United Kingdom