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Clinical Trials in the UK / NCT05897320
Recruiting Phase 3

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

NCT05897320 · tracked via the Priya Life Science UK tracker
Sponsor
H. Lundbeck A/S
Phase
Phase 3
Started
2023-06-08
Last updated
2026-09-09

Condition(s) studied

Episodic Migraine

Investigational drug(s) / intervention(s)

EptinezumabPlacebo

Eptinezumab: Solution for infusion

Placebo: Solution for infusion

Study summary

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

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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. * 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. * 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.

Primary outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
New England Institute for Clinical Research (NEICR) - Stamford Stamford Connecticut Recruiting
Child Neurology Center (CNC) of Northwest Florida Gulf Breeze Florida Recruiting
AGA Clinical Trials Hialeah Florida Recruiting
University of South Florida (USF) - Tampa Campus Tampa Florida Recruiting
Clinical Integrative Research Center of Atlanta (CIRCAtl) Atlanta Georgia Completed
UK HealthCare-Kentucky Clinic Lexington Kentucky Completed
University of Maryland School of Medicine Baltimore Maryland Completed
Michigan Headache & Neurological Institute (MHNI) Ann Arbor Michigan Completed
True North Neurology - Commack (North Suffolk Neurology) Commack New York Completed
OnSite Clinical Solutions, LLC - Charlotte Charlotte North Carolina Completed
Akron Children's Hospital Akron Ohio Recruiting
Cincinnati Children's Hospital Medical Center-Burnet Campus Cincinnati Ohio Recruiting
Road Runner Research (RRR) San Antonio Texas Recruiting
Children's Specialty Group (CSG) Norfolk Virginia Recruiting
Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus Milwaukee Wisconsin Recruiting
Hospital de Niños de la Santísima Trinidad Córdoba Córdoba Province Recruiting
Instituto Médico Río Cuarto Río Cuarto Córdoba Province Recruiting
INECO Neurociencias Oroño Rosario Santa Fe Province Recruiting
Centro de Investigaciones Medicas Tucuman San Miguel de Tucumán Tucumán Province Recruiting
Clinica Independencia Buenos Aires Argentina Completed
Mautalen Salud e Investigacion Buenos Aires Argentina Completed
Hospital Britanico de Buenos Aires (HOB) Buenos Aires Argentina Completed
The Medical Arts Health Research Group - Penticton Penticton British Columbia Completed
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic Victoria British Columbia Recruiting
Kids Clinic Ajax Ontario Recruiting
London Health Sciences Centre (LHSC) London Ontario Recruiting
L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret... Cagliari South Sardinia Recruiting
Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare Genoa Italy Recruiting
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Milan Italy Completed
Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico Pavia Italy Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To... Pisa Italy Recruiting
Ospedale Pediatrico Bambino Gesu - Gianicolo Rome Italy Recruiting
Centro de Investigacion Clinica de Morelia, S.C. Morelia Michoacán Completed
Clinical Research Institute SC-Mexico Tepetlacolco Mexico Recruiting
AthleticoMed Sp. z o.o. Bydgoszcz Kuyavian-Pomerania Recruiting
Centrum Medyczne Plejady Magdalena Celinska-Lowenhoff, Michal Zolnowski Spolka komandytowa Krakow Lesser Poland Voivodeship Recruiting
Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k Oświęcim Lesser Poland Voivodeship Recruiting
ETG Lublin Lublin Lublin Voivodeship Recruiting
MTZ Clinical Research Powered by PRATIA Warsaw Masovian Voivodeship Recruiting
European Trial group network Sp. z o.o - Neuroscience Warsaw Masovian Voivodeship Recruiting

+ 22 more sites — see the full list on the official registry below.

More H. Lundbeck A/S trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05897320 on ClinicalTrials.gov ↗ ← All trials in the UK