Phase
Condition
Oral Facial Pain
Pain
Chronic Pain
Treatment
Eptinezumab
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
The participant has an adverse event or other safety concerns that are deemedrelated to double-blind treatment received in the lead-in study and is considered apotential safety risk by the investigator.
During lead-in Study19356A or Study19357A:
participant experienced ananaphylactic reaction or another severe and/or serioushypersensitivity reaction to the investigational medicinal product (IMP) infusion,as assessed by the investigator
the participant had a serum alanine aminotransferase (ALT) or aspartateaminotransferase(AST) value >5 times the upper limit of the reference range that wasconfirmed by testing <2 weeks later.
the participant had a serum ALT or AST value >3times the upper limit of thereference range and a serum total bilirubin value >2times the upper limit of thereference range.
Study Design
Study Description
Connect with a study center
Hospital Privado de La Comunidad
Mar del Plata, Buenos Aires 7603
ArgentinaCompleted
Hospital Privado de La Comunidad
Mar del Plata 3430863, Buenos Aires 3435907 7603
ArgentinaSite Not Available
Expertia S.A- Mautalen Salud e Investigacion
Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires C1128AAF
ArgentinaActive - Recruiting
Expertia S.A- Mautalén Salud e Investigacion
Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires C1128AAF
ArgentinaSite Not Available
Expertia S.A- Mautalén Salud e Investigación
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1128AAF
ArgentinaSite Not Available
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires, Ciudad Autónoma de BuenosAires C1128AAF
ArgentinaCompleted
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires 3435910, Ciudad Autónoma de BuenosAires C1128AAF
ArgentinaSite Not Available
Hospital de Niños de La Santisima Trinidad
Cordoba-Barrio Crisol, Cordoba X5014AKM
ArgentinaSite Not Available
Hospital de Niños de La Santisima Trinidad
Córdoba-Barrio Crisol, Córdoba Province X5014AKM
ArgentinaActive - Recruiting
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province 5800
ArgentinaActive - Recruiting
Instituto Médico Río Cuarto
Río Cuarto 3838874, Córdoba Province 3860255 5800
ArgentinaSite Not Available
INECO Neurociencias Orono
Rosario, Santa Fe S2000DTP
ArgentinaActive - Recruiting
INECO Neurociencias Oroño
Rosario, Santa Fe Province S2000DTP
ArgentinaActive - Recruiting
INECO Neurociencias Oroño
Rosario 3838583, Santa Fe Province 3836276 S2000DTP
ArgentinaSite Not Available
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucuman, Tucuman T4000AXL
ArgentinaActive - Recruiting
Centro de Investigaciones Médicas Tucuman - PPDS
San Miguel de Tucuman, Tucuman T4000AXL
ArgentinaActive - Recruiting
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucuman, Tucumán T4000AXL
ArgentinaSite Not Available
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province T4000AXL
ArgentinaActive - Recruiting
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000AXL
ArgentinaSite Not Available
Hospital de Niños de La Santisima Trinidad
Cordoba,
ArgentinaSite Not Available
Vancouver Island Health Authority
Victoria, British Columbia V8R 1J8
CanadaActive - Recruiting
Vancouver Island Health Authority
Victoria 6174041, British Columbia 5909050 V8R 1J8
CanadaSite Not Available
The Kids Clinic
Ajax, Ontario L1Z 0M1
CanadaActive - Recruiting
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario N6A 5W9
CanadaActive - Recruiting
The Kids Clinic
Ajax 5882873, Ontario 6093943 L1Z 0M1
CanadaSite Not Available
London Health Sciences Centre -800 Commissioners Rd E
London 6058560, Ontario 6093943 N6A 5W9
CanadaSite Not Available
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Roma, Lazio 00165
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Roma, Lazio 00165
ItalySite Not Available
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, Lazio 00165
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome 3169070, Lazio 3174976 00165
ItalySite Not Available
IRCCS Istituto Giannina Gaslini
Genoa, Liguria 16147
ItalyActive - Recruiting
IRCCS Istituto Giannina Gaslini
Genova, Liguria 16147
ItalySite Not Available
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico
Genova, Liguria 16147
ItalyActive - Recruiting
IRCCS Istituto Giannina Gaslini
Genoa 3176219, Liguria 3174725 16147
ItalySite Not Available
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
Milano, Lombardia 20133
ItalyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano, Lombardia 20133
ItalySite Not Available
Ospedale San Raffaele S.r.l. - INCIPIT - PIN
Milano, Lombardia 20132
ItalyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy 20133
ItalyCompleted
Ospedale San Raffaele S.r.l. - INCIPIT - PIN
Milan, Lombardy 20132
ItalyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan 3173435, Lombardy 3174618 20133
ItalySite Not Available
Ospedale San Raffaele S.r.l. - INCIPIT - PIN
Milan 3173435, Lombardy 3174618 20132
ItalySite Not Available
AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
Cagliari, Sardinia 09121
ItalyActive - Recruiting
AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
Cagliari 2525473, Sardinia 2523228 09121
ItalySite Not Available
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Firenze, Toscana 50139
ItalySite Not Available
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany 50139
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, Tuscany 56126
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence 3176959, Tuscany 3165361 50139
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa 3170647, Tuscany 3165361 56126
ItalySite Not Available
Fondazione Istituto Neurologico Mondino IRCCS
Pavia, 27100
ItalyActive - Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, 27100
ItalyActive - Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia 3171366, 27100
ItalySite Not Available
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
Guadalajara, Jalisco 44700
MexicoActive - Recruiting
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
Guadalajara 4005539, Jalisco 4004156 44700
MexicoSite Not Available
Clinical Research Institute
Ampl San Lucas Tepetlacalco, México 54055
MexicoActive - Recruiting
Clinical Research Institute SC-Mexico
Ampl San Lucas Tepetlacalco, México 54055
MexicoActive - Recruiting
ICARO Investigaciones en Medicina, S.A de C.V
Chihuahua, 31000
MexicoSite Not Available
ICARO Investigaciones en Medicina, S.A de C.V
Chihuahua City, 31000
MexicoActive - Recruiting
ICARO Investigaciones en Medicina, S.A de C.V
Chihuahua City 4014338, 31000
MexicoSite Not Available
Instituto de Investigationes Clinicas para la Salud A.C.
Durango, 34000
MexicoActive - Recruiting
Instituto de Investigationes Clinicas para la Salud A.C.
Durango 4011743, 34000
MexicoSite Not Available
AthleticoMed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-752
PolandActive - Recruiting
AthleticoMed
Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-752
PolandSite Not Available
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow, Lesser Poland Voivodeship 30-363
PolandActive - Recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, Lesser Poland Voivodeship 32-600
PolandActive - Recruiting
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow 3094802, Lesser Poland Voivodeship 858786 30-363
PolandSite Not Available
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim 3089658, Lesser Poland Voivodeship 858786 32-600
PolandSite Not Available
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship 52-210
PolandActive - Recruiting
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw 3081368, Lower Silesian Voivodeship 3337492 52-210
PolandSite Not Available
ETG Lublin - PPDS
Lublin, Lublin Voivodeship 20-412
PolandActive - Recruiting
ETG Lublin - PPDS
Lublin 765876, Lublin Voivodeship 858785 20-412
PolandSite Not Available
ETG Neuroscience - PPDS
Warsaw, Masovian Voivodeship 02-677
PolandActive - Recruiting
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship 02-172
PolandActive - Recruiting
ETG Neuroscience - PPDS
Warsaw 756135, Masovian Voivodeship 858787 02-677
PolandActive - Recruiting
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw 756135, Masovian Voivodeship 858787 02-172
PolandSite Not Available
ULS de Santo Antonio, EPE - Centro Materno Infantil Norte
Porto Covo, Setúbal 4050-651
PortugalActive - Recruiting
ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
Almada, Setúbal District 2805-267
PortugalActive - Recruiting
ULS de Santo António, EPE - Centro Materno Infantil Norte
Porto Covo, Setúbal District 4050-651
PortugalActive - Recruiting
ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
Almada 2271961, Setúbal District 2262961 2805-267
PortugalSite Not Available
ULS de Santo António, EPE - Centro Materno Infantil Norte
Porto Covo 2264442, Setúbal District 2262961 4050-651
PortugalSite Not Available
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243
PortugalActive - Recruiting
Centro Clínico Académico, Braga - Hospital de Braga
Braga 2742032, 4710-243
PortugalSite Not Available
Hospital Pediatrico de Coimbra
Coimbra, 3000-602
PortugalActive - Recruiting
ULS de Coimbra, EPE - Hospital Pediatrico de Coimbra
Coimbra, 3000-602
PortugalActive - Recruiting
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, 3000-602
PortugalActive - Recruiting
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra 2740637, 3000-602
PortugalSite Not Available
ULS de São João, EPE - Hospital de São João
Porto, 4200-319
PortugalActive - Recruiting
ULS de São João, EPE - Hospital de São João
Porto 2735943, 4200-319
PortugalSite Not Available
Childrens University Hospital
Beograd, Belgrade 11000
SerbiaSite Not Available
Childrens University Hospital
Belgrade, 11000
SerbiaActive - Recruiting
Childrens University Hospital
Belgrade 792680, 11000
SerbiaSite Not Available
University Clinical Center Kragujevac
Kragujevac, 34000
SerbiaActive - Recruiting
University Clinical Center Kragujevac
Kragujevac 789128, 34000
SerbiaSite Not Available
University Clinical Center Nis
Nis, 18 000
SerbiaSite Not Available
University Clinical Center Nis
Niš, 18 000
SerbiaActive - Recruiting
University Clinical Center Nis
Niš 787657, 18 000
SerbiaSite Not Available
Children and Youth Health Care Institute of Vojvodina
Novi Sad, 21 000
SerbiaActive - Recruiting
Clinical Centre of Vojvodina
Novi Sad, 21 000
SerbiaActive - Recruiting
Children and Youth Health Care Institute of Vojvodina
Novi Sad 3194360, 21 000
SerbiaActive - Recruiting
Clinical Centre of Vojvodina
Novi Sad 3194360, 21 000
SerbiaSite Not Available
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra 36312
SpainActive - Recruiting
CHUVI - H.U. Alvaro Cunqueiro
Vigo 3105976, Pontevedra 36312
SpainSite Not Available
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8025
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona 3128760, 8025
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hospital Clinico San Carlos
Madrid 3117735, 28040
SpainSite Not Available
Hospital Universitario Virgen del Rocio - PPDS
Sevilla, 41013
SpainSite Not Available
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio - PPDS
Seville 2510911, 41013
SpainSite Not Available
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia 2509954, 46026
SpainSite Not Available
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
Eskisehir, 26480
TurkeySite Not Available
Mersin University Medical Faculty
Mersin, 33169
TurkeySite Not Available
Izmir City Hospital
Bayraklı, İzmir 35540
Turkey (Türkiye)Active - Recruiting
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
Eskişehir, 26480
Turkey (Türkiye)Active - Recruiting
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
Eskişehir 315202, 26480
Turkey (Türkiye)Site Not Available
Mersin University Medical Faculty
Mersin, 33169
Turkey (Türkiye)Active - Recruiting
Mersin University Medical Faculty
Mersin 304531, 33169
Turkey (Türkiye)Site Not Available
Great Ormond Street Hospital
London, London, City Of WC1N 3JH
United KingdomActive - Recruiting
Great Ormond Street Hospital for Children
London, London, City Of WC1N 3JH
United KingdomActive - Recruiting
Great Ormond Street Hospital - PPDS
London, London, City of WC1N 3JH
United KingdomActive - Recruiting
Great Ormond Street Hospital - PPDS
London 2643743, London, City of WC1N 3JH
United KingdomSite Not Available
Royal Hospital for Children and Young People - PIN
Edinburgh, Midlothian EH16 4TJ
United KingdomActive - Recruiting
Royal Hospital for Children and Young People - PIN
Edinburgh 2650225, Midlothian EH16 4TJ
United KingdomSite Not Available
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk NR31 6LA
United KingdomActive - Recruiting
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth 2647984, Norfolk NR31 6LA
United KingdomSite Not Available
Queen Elizabeth University Hospital - PPDS
Glasgow, G514TF
United KingdomActive - Recruiting
Queen Elizabeth University Hospital - PPDS
Glasgow 2648579, G514TF
United KingdomSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06511
United StatesActive - Recruiting
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut 06905-1206
United StatesActive - Recruiting
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford 4843564, Connecticut 4831725 06905-1206
United StatesSite Not Available
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida 32561-4458
United StatesActive - Recruiting
A G A Clinical Trials
Hialeah, Florida 33012-3402
United StatesSite Not Available
A G A Clinical Trials - HyperCore - PPDS
Hialeah, Florida 33012-3402
United StatesActive - Recruiting
AGA Clinical Trials
Hialeah, Florida 33012
United StatesActive - Recruiting
AGA Clinical Trials - Hialeah - 4980 W 10th Ave
Hialeah, Florida 33012
United StatesActive - Recruiting
Axcess Medical Research
Loxahatchee Groves, Florida 33470-9272
United StatesCompleted
University of South Florida
Tampa, Florida 33612-6601
United StatesActive - Recruiting
NW FL Clinical Research Group, LLC
Gulf Breeze 4157634, Florida 4155751 32561-4458
United StatesSite Not Available
A G A Clinical Trials
Hialeah 4158476, Florida 4155751 33012-3402
United StatesActive - Recruiting
AGA Clinical Trials
Hialeah 4158476, Florida 4155751 33012
United StatesSite Not Available
Axcess Medical Research
Loxahatchee Groves 4162948, Florida 4155751 33470-9272
United StatesSite Not Available
University of South Florida
Tampa 4174757, Florida 4155751 33612-6601
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536-7001
United StatesActive - Recruiting
University of Kentucky
Lexington 4297983, Kentucky 6254925 40536-7001
United StatesSite Not Available
University of Maryland School of Medicine
Baltimore, Maryland 21201-1544
United StatesActive - Recruiting
University of Maryland School of Medicine
Baltimore 4347778, Maryland 4361885 21201-1544
United StatesSite Not Available
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan 48104-5131
United StatesCompleted
Michigan State University - Department of Neurology
East Lansing, Michigan 48824-7015
United StatesCompleted
Devos Childrens Hospital
Grand Rapids, Michigan 49503-2528
United StatesActive - Recruiting
Helen DeVos Children Hospital
Grand Rapids, Michigan 49503-2514
United StatesActive - Recruiting
Helen Devos Childrens' Hospital
Grand Rapids, Michigan 49503-2528
United StatesSite Not Available
Helen Devos Childrens' Hospital - PIN
Grand Rapids, Michigan 49503-2528
United StatesActive - Recruiting
Michigan Head Pain and Neurological Institute
Ann Arbor 4984247, Michigan 5001836 48104-5131
United StatesSite Not Available
Michigan State University - Department of Neurology
East Lansing 4991640, Michigan 5001836 48824-7015
United StatesSite Not Available
Helen Devos Childrens' Hospital - PIN
Grand Rapids 4994358, Michigan 5001836 49503-2528
United StatesSite Not Available
Dent Neurosciences Research Center Incorporated
Amherst, New York 14226-1727
United StatesCompleted
North Suffolk Neurology-Commack
Commack, New York 11725-2808
United StatesActive - Recruiting
True North Neurology
Commack, New York 11725-2808
United StatesActive - Recruiting
Dent Neurosciences Research Center Incorporated
Amherst 5107129, New York 5128638 14226-1727
United StatesSite Not Available
True North Neurology
Commack 5113412, New York 5128638 11725-2808
United StatesSite Not Available
OnSite Clinical Solutions, LLC - Charlotte - ClinEdge - PPDS
Charlotte, North Carolina 28211-5027
United StatesActive - Recruiting
OnSite Clinical Solutions, LLC - ClinEdge - PPDS
Charlotte, North Carolina 28226-8380
United StatesActive - Recruiting
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte, North Carolina 28211-5027
United StatesCompleted
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
Charlotte, North Carolina 28211-5027
United StatesSite Not Available
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte 4460243, North Carolina 4482348 28211-5027
United StatesSite Not Available
Childrens Hospital Medical Center of Akron
Akron, Ohio 44308-1063
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio 45229-3026
United StatesActive - Recruiting
Childrens Hospital Medical Center of Akron
Akron 5145476, Ohio 5165418 44308-1063
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati 4508722, Ohio 5165418 45229-3026
United StatesSite Not Available
Road Runner Research Ltd
San Antonio, Texas 78249-3539
United StatesActive - Recruiting
Road Runner Research Ltd
San Antonio 4726206, Texas 4736286 78249-3539
United StatesSite Not Available
Children's Specialty Group - 3 Commercial Place
Norfolk, Virginia 23510
United StatesActive - Recruiting
Children's Specialty Group - 3 Commercial Place
Norfolk 4776222, Virginia 6254928 23510
United StatesSite Not Available
Marshall University Medical Center
Huntington, West Virginia 25701-3656
United StatesActive - Recruiting
Marshall University Medical Center
Huntington 4809537, West Virginia 4826850 25701-3656
United StatesSite Not Available
Children's Wisconsin - Milwaukee Campus
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Children's Wisconsin - Milwaukee Campus - PIN
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Children's Wisconsin - Milwaukee Campus
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesActive - Recruiting
Children's Wisconsin - Milwaukee Campus - PIN
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

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