A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
NCT ID: NCT04965675
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
285 participants
INTERVENTIONAL
2021-06-30
2026-10-31
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 a single IV infusion of eptinezumab 300 mg (weight adjusted).
Eptinezumab
Eptinezumab will be administered per dose and schedule specified in the arm.
Eptinezumab 100 mg
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Eptinezumab
Eptinezumab will be administered per dose and schedule specified in the arm.
Placebo
Participants will receive a single IV infusion of placebo matching to eptinezumab.
Placebo
Placebo matching to eptinezumab will be administered per schedule specified in the arm.
Interventions
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Eptinezumab
Eptinezumab will be administered per dose and schedule specified in the arm.
Placebo
Placebo matching to eptinezumab will be administered per schedule specified in the arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
* During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.
Exclusion Criteria
* The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
* The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit.
* The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).
12 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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Yale-New Haven Children's Hospital - PIN
New Haven, Connecticut, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, 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 HealthCare (UKHC) Kentucky Clinic
Lexington, Kentucky, United States
University of Maryland
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
Corewell Health Butterworth Hospital
Grand Rapids, Michigan, United States
Dent Neurosciences Research Center Incorporated
Amherst, New York, United States
North Suffolk Neurology-Commack
Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Road Runner Research Ltd
San Antonio, Texas, United States
Children's Specialty Group
Norfolk, Virginia, United States
Mary Bridge Children's Hospital
Tacoma, Washington, United States
Marshall University Medical Center
Huntington, West Virginia, United States
Hospital Privado de La Comunidad
Mar del Plata, Buenos Aires, Argentina
Clínica Privada Independencia
Munro, Buenos Aires, Argentina
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autónoma Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Sanatorio Allende S.A
Córdoba, Córdoba Province, 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
University of Alberta
Edmonton, Alberta, Canada
Medical Arts Health Research Group - Penticton
Penticton, British Columbia, Canada
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
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Apulia, Italy
Ospedale Pediatrico Bambino Gesù IRCCS
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
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, 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
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
Guadalajara, Jalisco, Mexico
Unidad de Investigación en Salud de Chihuahua S.C.
Zapopan, Jalisco, Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia
Morelia, Michoacán, Mexico
ICARO Investigaciones en Medicina, S.A de C.V
Chihuahua City, , Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán Sinaloa, , Mexico
Instituto de Investigationes Clinicas para la Salud A.C.
Durango, , Mexico
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
Mexico City, , Mexico
Clinical Research Institute SC-Mexico
Tepetlacolco, , Mexico
Centro de Estudios Clinicos Y Especialidades Medicas SC
Vista Hermosa, , Mexico
AthleticoMed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
ETG Neuroscience - PPDS
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
Krakow, , Poland
ETG Lublin - PPDS
Lublin, , Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, , Poland
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, , Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, , Poland
ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
Almada, Setúbal District, 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
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
Instituto del Sueño
Madrid, , 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
Izmir City Hospital
Bayraklı, İzmir, Turkey (Türkiye)
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
Eskişehir, , Turkey (Türkiye)
Istanbul Üniversitesi, Istanbul Tip Fakültesi, Nör
Fatih/Istanbul, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty Hospital
Fatih/Istanbul, , Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, , Turkey (Türkiye)
Royal Devon and Exeter Hospital NHS Trust - PPDS
Exeter, Devon, United Kingdom
Queen Elizabeth University Hospital - PPDS
Glasgow, Lanarkshire, United Kingdom
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
Countries
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Central Contacts
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Other Identifiers
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2020-001009-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-510656-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
19356A
Identifier Type: -
Identifier Source: org_study_id