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NCT04965675RecruitingPhase 3

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

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
285 (estimated)
First submitted
7 Jul 2021
Start date
30 Jun 2021
Primary completion date
26 Mar 2027
Lead sponsor
H. Lundbeck A/S
Diseases
Migraine
NCT number
NCT04965675
EU CT number
2024-510656-13-00
EudraCT number
2020-001009-22

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 285
  • From 30 Jun 2021 to the primary completion date, 26 Mar 2027
  • 82 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The participant has previously been randomised in this study and exposed to eptinezumab.
  • 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.

Other

  • 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).

Who the study is looking for

  • The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
  • 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.

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (82)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Italiano de Buenos Aires (HIBA) - Centro de Esclerosis Multiple Buenos Aires (CEMBA)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaCompleted
Clinica Independencia
Coordinator of this site? Confirm its status
Buenos AiresArgentinaCompleted
Mautalen Salud e Investigación
Coordinator of this site? Confirm its status
Buenos AiresArgentinaCompleted
Hospital Britanico de Buenos Aires (HOB)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaCompleted
Hospital de Niños de la Santísima Trinidad
Coordinator of this site? Confirm its status
CórdobaArgentinaRecruiting
Sanatorio Allende S.A.
Coordinator of this site? Confirm its status
CórdobaArgentinaCompleted
Hospital Privado de Comunidad (HPC)
Coordinator of this site? Confirm its status
Mar del PlataArgentinaCompleted
Instituto Médico Río Cuarto
Coordinator of this site? Confirm its status
Río CuartoArgentinaRecruiting
INECO Neurociencias Oroño
Coordinator of this site? Confirm its status
RosarioArgentinaRecruiting
Centro de Investigaciones Medicas Tucuman
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaRecruiting
Kids Clinic
Coordinator of this site? Confirm its status
AjaxCanadaRecruiting
University of Alberta Hospital (UAH)
Coordinator of this site? Confirm its status
EdmontonCanadaCompleted
London Health Sciences Centre (LHSC)
Coordinator of this site? Confirm its status
LondonCanadaRecruiting
The Medical Arts Health Research Group - Penticton
Coordinator of this site? Confirm its status
PentictonCanadaCompleted
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic
Coordinator of this site? Confirm its status
VictoriaCanadaRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Alvaro Cunqueiro
Coordinator of this site? Confirm its status
VigoSpainActive, not recruiting
NHS Lothian - Royal Hospital for Children & Young People (RHCYP)
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting
Royal Devon and Exeter Hospital NHS Trust - PPDS
Coordinator of this site? Confirm its status
ExeterUnited KingdomCompleted
NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...
Coordinator of this site? Confirm its status
GlasgowUnited KingdomRecruiting
James Paget University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
Great YarmouthUnited KingdomRecruiting
Great Ormond Street Hospital For Children NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomCompleted
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
Coordinator of this site? Confirm its status
CagliariItalyActive, not recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Coordinator of this site? Confirm its status
FlorenceItalyActive, not recruiting
IRCCS Istituto Giannina Gaslini
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GenoaItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyActive, not recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyActive, not recruiting
Ospedale Pediatrico Bambino Gesù
Coordinator of this site? Confirm its status
RomeItalyActive, not recruiting
Icaro Investigaciones en Medicina S.A. de C.V.
Coordinator of this site? Confirm its status
Chihuahua CityMexicoRecruiting
Neurociencias Estudios Clinicos S.C.
Coordinator of this site? Confirm its status
CuliacánMexicoCompleted
Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C)
Coordinator of this site? Confirm its status
DurangoMexicoRecruiting
Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA)
Coordinator of this site? Confirm its status
GuadalajaraMexicoRecruiting
Unidad de Investigación en Salud de Chihuahua S.C.
Coordinator of this site? Confirm its status
MéxicoMexicoCompleted
Centro de Estudios Clinicos y Especialidades Medicas SC
Coordinator of this site? Confirm its status
MonterreyMexicoCompleted
Centro de Investigacion Clinica de Morelia, S.C.
Coordinator of this site? Confirm its status
MoreliaMexicoCompleted
Clinical Research Institute SC-Mexico
Coordinator of this site? Confirm its status
TepetlacolcoMexicoRecruiting
Unidad de Investigación en Salud de Chihuahua S.C.
Coordinator of this site? Confirm its status
ZapopanMexicoCompleted
Athleticomed Sp. z o.o.
Coordinator of this site? Confirm its status
BydgoszczPolandActive, not recruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandActive, not recruiting
ETG Lublin Sp. z o.o.
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LublinPolandActive, not recruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
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OswiecimPolandActive, not recruiting
ETG Neuroscience Sp. z o.o.
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WarsawPolandActive, not recruiting
MTZ Clinical Research powered by Pratia
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Coordinator of this site? Confirm its status
WrocławPolandActive, not recruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
Coordinator of this site? Confirm its status
AlmadaPortugalActive, not recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalActive, not recruiting
Unidade Local de Saude de Sao Joao E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalActive, not recruiting
Univerzitetska Decija Klinika (UDK) (University Children's Hospital)
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
Clinical Center Kragujevac
Coordinator of this site? Confirm its status
KragujevacSerbiaRecruiting
University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic
Coordinator of this site? Confirm its status
Novi SadSerbiaRecruiting
Institute of Child and Youth Health Care of Vojvodina
Coordinator of this site? Confirm its status
Novi SadSerbiaRecruiting
Dent Neurosciences Research Center
Coordinator of this site? Confirm its status
AmherstUnited StatesCompleted
Michigan Headache & Neurological Institute (MHNI)
Coordinator of this site? Confirm its status
Ann ArborUnited StatesCompleted
Clinical Integrative Research Center of Atlanta (CIRCAtl)
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AtlantaUnited StatesCompleted
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
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BaltimoreUnited StatesCompleted
OnSite Clinical Solutions, LLC - Charlotte
Coordinator of this site? Confirm its status
CharlotteUnited StatesCompleted
Cincinnati Children's Hospital Medical Center-Burnet Campus
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CincinnatiUnited StatesRecruiting
True North Neurology - Commack (North Suffolk Neurology)
Coordinator of this site? Confirm its status
CommackUnited StatesCompleted
Sarkis Clinical Trials - Gainsville
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GainesvilleUnited StatesCompleted
Corewell Health - Butterworth Hospital
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Grand RapidsUnited StatesCompleted
NW FL Clinical Research Group, LLC
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Gulf BreezeUnited StatesRecruiting
AGA Clinical Trials
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HialeahUnited StatesRecruiting
Marshall Health-Marshall University Medical Center
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HuntingtonUnited StatesRecruiting
UK HealthCare-Kentucky Clinic
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LexingtonUnited StatesRecruiting
Axcess Medical Research - Loxahatchee
Coordinator of this site? Confirm its status
Loxahatchee GrovesUnited StatesCompleted
Yale-New Haven Children's Hospital
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New HavenUnited StatesCompleted
Children's Specialty Group (CSG)
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NorfolkUnited StatesRecruiting
University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center
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Oklahoma CityUnited StatesCompleted
Road Runner Research (RRR)
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San AntonioUnited StatesRecruiting
New England Institute for Clinical Research (NEICR) - Stamford
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StamfordUnited StatesRecruiting
MultiCare Mary Bridge Children's Hospital and Health Center
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TacomaUnited StatesCompleted
University of South Florida (USF) - Tampa Campus
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TampaUnited StatesRecruiting
Children's National Hospital - Children's National Heart Center
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Washington D.C.United StatesCompleted
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)
Coordinator of this site? Confirm its status
EskişehirTurkey (Türkiye)Recruiting
Istanbul Universitesi - Cerrahpasa Tip Fakultesi (Cerrahpasa Medical Faculty)
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FatihTurkey (Türkiye)Completed
Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
İzmir Şehir Hastanesi
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IzmirTurkey (Türkiye)Recruiting
Mersin Universitesi Tip Fakultesi
Coordinator of this site? Confirm its status
MersinTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.