A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
NCT ID: NCT05164172
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2021-12-01
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Eptinezumab 300 mg
Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
Eptinezumab
Concentrate for solution for infusion
Eptinezumab 100 mg
Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
Eptinezumab
Concentrate for solution for infusion
Interventions
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Eptinezumab
Concentrate for solution for infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
6 Years
17 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Email contact via H. Lundbeck A/S
Role: STUDY_DIRECTOR
H. Lundbeck A/S
Locations
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Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
A G A Clinical Trials
Hialeah, Florida, United States
Axcess Medical Research
Loxahatchee Groves, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Michigan State University - Department of Neurology
East Lansing, Michigan, United States
Helen Devos Childrens' Hospital - PIN
Grand Rapids, Michigan, United States
Dent Neurosciences Research Center Incorporated
Amherst, New York, United States
True North Neurology
Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte, North Carolina, United States
Childrens Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States
Road Runner Research Ltd
San Antonio, Texas, United States
Children's Specialty Group - 3 Commercial Place
Norfolk, Virginia, United States
Marshall University Medical Center
Huntington, West Virginia, United States
Children's Wisconsin - Milwaukee Campus
Milwaukee, Wisconsin, United States
Hospital Privado de La Comunidad
Mar del Plata, Buenos Aires, Argentina
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Hospital de Niños de La Santisima Trinidad
Córdoba-Barrio Crisol, Córdoba Province, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province, Argentina
Vancouver Island Health Authority
Victoria, British Columbia, Canada
The Kids Clinic
Ajax, Ontario, Canada
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario, Canada
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, Lazio, Italy
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, Italy
Ospedale San Raffaele S.r.l. - INCIPIT - PIN
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
Cagliari, Sardinia, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, Tuscany, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, , Italy
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
Guadalajara, Jalisco, Mexico
Clinical Research Institute SC-Mexico
Ampl San Lucas Tepetlacalco, México, Mexico
ICARO Investigaciones en Medicina, S.A de C.V
Chihuahua City, , Mexico
Instituto de Investigationes Clinicas para la Salud A.C.
Durango, , Mexico
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow, Lesser Poland Voivodeship, Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, Lesser Poland Voivodeship, Poland
ETG Neuroscience - PPDS
Warsaw, Masovian Voivodeship, Poland
ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
Almada, Setúbal District, Portugal
ULS de Santo António, EPE - Centro Materno Infantil Norte
Porto Covo, Setúbal District, Portugal
Centro Clínico Académico, Braga - Hospital de Braga
Braga, , Portugal
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, , Portugal
ULS de São João, EPE - Hospital de São João
Porto, , Portugal
Childrens University Hospital
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
University Clinical Center Nis
Niš, , Serbia
Children and Youth Health Care Institute of Vojvodina
Novi Sad, , Serbia
Clinical Centre of Vojvodina
Novi Sad, , Serbia
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
Eskişehir, , Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, , Turkey (Türkiye)
Great Ormond Street Hospital - PPDS
London, London, City of, United Kingdom
Royal Hospital for Children and Young People - PIN
Edinburgh, Midlothian, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, United Kingdom
Queen Elizabeth University Hospital - PPDS
Glasgow, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2022-502917-27-00
Identifier Type: OTHER
Identifier Source: secondary_id
19379A
Identifier Type: -
Identifier Source: org_study_id