Phase
Condition
Migraine (Adult)
Migraine (Pediatric)
Oral Facial Pain
Treatment
Eptinezumab
Placebo
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of migraine (with or without aura) according to the InternationalClassification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of theinvestigator) with history of migraine headaches of at least 6 months prior to theScreening Visit.
During the 28-day screening period, the participant (and their parent/caregiver,when applicable) must adequately complete the headache eDiary (≥23 of the 28 days)following the day of the Screening Visit.
During the 28-day screening period, the participant must have ≤14 headache days, ofwhich at least 4 are migraine days as documented in the eDiary.
Exclusion
Exclusion Criteria:
History or diagnosis of chronic tension-type headache, hypnic headache, clusterheadache, hemicrania continua, new daily persistent headache, or unusual migrainesubtypes (previously referred to as complicated migraine), such as hemiplegicmigraine (sporadic and familial), migraine with brainstem aura, recurrent painfulophthalmic neuropathy, or migraine with neurological accompaniments that are nottypical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min).
History of moderate or severe head trauma or other neurological disorder or systemicmedical disease that is, in the investigator's opinion, likely to affect thefunctions of the central nervous system.
Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history ofpsychosis and/or mania are excluded.
Any other disorder for which the treatment takes priority over treatment of migraineor is likely to interfere with study treatment or impair treatment compliance.
Other inclusion and exclusion criteria may apply.
Study Design
Connect with a study center
Clínica Privada Independencia
Munro, Buenos Aires 1605
ArgentinaActive - Recruiting
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
Hospital Britanico de Buenos Aires
Barracas, Ciudad Autónoma De BuenosAires C1280AEB
ArgentinaActive - Recruiting
Expertia S.A- Mautalén Salud e Investigación
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1128AAF
ArgentinaActive - Recruiting
Instituto Médico Río Cuarto
Río Cuarto, Córdoba 5800
ArgentinaActive - Recruiting
INECO Neurociencias Orono
Rosario, Santa Fe S2000DTP
ArgentinaActive - Recruiting
INECO Neurociencias Oroño
Rosario, Santa Fe S2000DTP
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
ArgentinaActive - Recruiting
Hospital de Niños de La Santisima Trinidad
Cordoba,
ArgentinaActive - Recruiting
Medical Arts Health Research Group - Penticton
Penticton, British Columbia V2A 5L5
CanadaCompleted
Vancouver Island Health Authority
Victoria, British Columbia V8R 1J8
CanadaActive - Recruiting
The Kids Clinic
Ajax, Ontario L1Z 0M1
CanadaActive - Recruiting
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario N6A 5W9
CanadaActive - Recruiting
Ospedale Pediatrico Bambino Gesù IRCCS
Roma, Lazio 00165
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesù IRCCS
Roma, Lazio 00165
ItalyActive - Recruiting
Istituto G Gaslini Ospedale Pediatrico IRCCS
Genova, Liguria 16147
ItalyActive - Recruiting
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
ItalyActive - Recruiting
Ospedale San Raffaele S.r.l. - PPDS
Milano, Lombardia 20132
ItalyActive - Recruiting
Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardia 27100
ItalyActive - Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardia 27100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Firenze, Toscana 50139
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, Toscana 56126
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana-Via Roma 67
Pisa, Toscana 56126
ItalyActive - Recruiting
Clinical Research Institute SC-Mexico
Tepetlacalco, 54055
MexicoActive - Recruiting
Centro Materno Infantil do Norte
Porto Covo, Setúbal 4050-651
PortugalActive - Recruiting
ULS de Santo Antonio, EPE - Centro Materno Infantil Norte
Porto Covo, Setúbal 4050-651
PortugalActive - Recruiting
ULS de Santo António, EPE - Centro Materno Infantil Norte
Porto Covo, Setúbal 4050-651
PortugalActive - Recruiting
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243
PortugalActive - Recruiting
Hospital de Braga
Braga, 4710-243
PortugalActive - Recruiting
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
Hospital CUF Descobertas
Lisboa, 1998-018
PortugalActive - Recruiting
ULS de São João, EPE - Hospital de São João
Porto Covo, 4200-319
PortugalActive - Recruiting
Childrens University Hospital
Belgrade, 11000
SerbiaActive - Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
SerbiaActive - Recruiting
University Clinical Center Nis
Nis, 18 000
SerbiaActive - Recruiting
Children and Youth Health Care Institute of Vojvodina
Novi Sad, 21 000
SerbiaActive - Recruiting
Clinical Centre of Vojvodina
Novi Sad, 21000
SerbiaActive - Recruiting
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra 36312
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8025
SpainActive - Recruiting
Hospital Clinico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
SpainActive - Recruiting
Izmir City Hospital
Bayraklı, Izmir 35540
TurkeyActive - Recruiting
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
Eskisehir, 26480
TurkeyActive - Recruiting
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Fatih/Istanbul, 34093
TurkeyActive - Recruiting
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33169
TurkeyActive - Recruiting
Royal Hospital for Children (Glasgow) - PPDS - PIN
Glasgow, Glasgow City G514TF
United KingdomActive - Recruiting
Royal Hospital for Children and Young People
Edinburgh, Midlothian EH16 4TJ
United KingdomActive - Recruiting
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk NR31 6LA
United KingdomActive - Recruiting
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut 06905-1206
United StatesActive - Recruiting
Child Neurology of NW Florida
Gulf Breeze, Florida 32561-4495
United StatesActive - Recruiting
A G A Clinical Trials - HyperCore - PPDS
Hialeah, Florida 33012-3407
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33612
United StatesActive - Recruiting
University of Kentucky HealthCare (UKHC) Kentucky Clinic
Lexington, Kentucky 40508-1683
United StatesActive - Recruiting
University of Maryland School of Medicine
Baltimore, Maryland 21201-1544
United StatesActive - Recruiting
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan 48104-5131
United StatesActive - Recruiting
North Suffolk Neurology-Commack
Commack, New York 11725-2808
United StatesActive - Recruiting
OnSite Clinical Solutions, LLC - Charlotte - ClinEdge - PPDS
Charlotte, North Carolina 28211-5027
United StatesActive - Recruiting
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
Charlotte, North Carolina 28211-5027
United StatesActive - Recruiting
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
Road Runner Research Ltd
San Antonio, Texas 78249-3539
United StatesActive - Recruiting
Children's Specialty Group
Norfolk, Virginia 23510-1021
United StatesActive - Recruiting
Children's Specialty Group - 3 Commercial Place
Norfolk, Virginia 23510
United StatesActive - Recruiting
Childrens Hospital of Wisconsin
New Berlin, Wisconsin 53151-7494
United StatesActive - Recruiting
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