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