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