Sign in

NCT05897320RecruitingPhase 3

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
315 (estimated)
First submitted
31 May 2023
Start date
8 Jun 2023
Primary completion date
6 Jul 2027
Lead sponsor
H. Lundbeck A/S
Diseases
Migraine
NCT number
NCT05897320
EU CT number
2022-502538-14-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 315
  • From 8 Jun 2023 to the primary completion date, 6 Jul 2027
  • 60 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

  • History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min).
  • 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 of psychosis and/or mania are excluded.

Other illness

  • History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
  • Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.
    • Other inclusion and exclusion criteria may apply.

Who the study is looking for

  • Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening 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, of which at least 4 are migraine days as documented in the eDiary.

Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Britanico de Buenos Aires (HOB)
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 de Niños de la Santísima Trinidad
Coordinator of this site? Confirm its status
CórdobaArgentinaRecruiting
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
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
BarcelonaSpainRecruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC)
Coordinator of this site? Confirm its status
VigoSpainRecruiting
NHS Lothian - Royal Hospital for Children & Young People (RHCYP)
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting
NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...
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 KingdomRecruiting
L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...
Coordinator of this site? Confirm its status
CagliariItalyCompleted
Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare
Coordinator of this site? Confirm its status
GenoaItalyRecruiting
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyCompleted
Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico
Coordinator of this site? Confirm its status
PaviaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To...
Coordinator of this site? Confirm its status
PisaItalyRecruiting
Ospedale Pediatrico Bambino Gesu - Gianicolo
Coordinator of this site? Confirm its status
RomeItalyRecruiting
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
Centrum Medyczne Plejady
Coordinator of this site? Confirm its status
KrakowPolandRecruiting
ETG Lublin
Coordinator of this site? Confirm its status
LublinPolandRecruiting
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Coordinator of this site? Confirm its status
OświęcimPolandRecruiting
European Trial group network Sp. z o.o - Neuroscience
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
MTZ Clinical Research powered by Pratia
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Hospital de Braga
Coordinator of this site? Confirm its status
BragaPortugalRecruiting
Hospital Pediátrico de Coimbra
Coordinator of this site? Confirm its status
CoimbraPortugalRecruiting
Hospital Cuf Descobertas S.A.
Coordinator of this site? Confirm its status
LisbonPortugalCompleted
Centro Hospitalar Universitario de Sao Joao (CHUSJ)
Coordinator of this site? Confirm its status
PortoPortugalRecruiting
Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)
Coordinator of this site? Confirm its status
PortoPortugalRecruiting
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 Clinical Center NIS
Coordinator of this site? Confirm its status
NišSerbiaRecruiting
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
Akron Children's Hospital
Coordinator of this site? Confirm its status
AkronUnited StatesRecruiting
Michigan Headache & Neurological Institute (MHNI)
Coordinator of this site? Confirm its status
Ann ArborUnited StatesCompleted
Clinical Integrative Research Center of Atlanta (CIRCAtl)
Coordinator of this site? Confirm its status
AtlantaUnited StatesCompleted
University of Maryland School of Medicine
Coordinator of this site? Confirm its status
BaltimoreUnited StatesCompleted
OnSite Clinical Solutions, LLC - Charlotte
Coordinator of this site? Confirm its status
CharlotteUnited StatesCompleted
Cincinnati Children's Hospital Medical Center-Burnet Campus
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
True North Neurology - Commack (North Suffolk Neurology)
Coordinator of this site? Confirm its status
CommackUnited StatesCompleted
Child Neurology Center (CNC) of Northwest Florida
Coordinator of this site? Confirm its status
Gulf BreezeUnited StatesRecruiting
AGA Clinical Trials
Coordinator of this site? Confirm its status
HialeahUnited StatesRecruiting
UK HealthCare-Kentucky Clinic
Coordinator of this site? Confirm its status
LexingtonUnited StatesCompleted
Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesRecruiting
Children's Specialty Group (CSG)
Coordinator of this site? Confirm its status
NorfolkUnited StatesRecruiting
Road Runner Research (RRR)
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
New England Institute for Clinical Research (NEICR) - Stamford
Coordinator of this site? Confirm its status
StamfordUnited StatesRecruiting
University of South Florida (USF) - Tampa Campus
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)
Coordinator of this site? Confirm its status
EskişehirTurkey (Türkiye)Recruiting
Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
İzmir Şehir Hastanesi
Coordinator of this site? Confirm its status
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.