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A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

NCT ID: NCT05897320
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: H. Lundbeck A/S
Conditions: Episodic Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 315 participants (Estimated).

What is being studied

Intervention: eptinezumab
Drug: Eptinezumab
Drug: Placebo

Who may be eligible

Ages: 6 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

62 study locations are listed.

Recruiting site status is explicitly provided for 62 locations; 49 are listed as Recruiting.

Countries: Argentina, Canada, Italy, Mexico, Poland, Portugal, Serbia, Spain, Turkey (Türkiye), United Kingdom, United States

Córdoba Province, Argentina: 2
Santa Fe Province, Argentina: 1
Tucumán Province, Argentina: 1
British Columbia, Canada: 2
Ontario, Canada: 2
South Sardinia, Italy: 1
Michoacán, Mexico: 1
Kuyavian-Pomerania, Poland: 1
Lesser Poland Voivodeship, Poland: 2
Lublin Voivodeship, Poland: 1
Masovian Voivodeship, Poland: 2
Beograd, Serbia: 1
Juznobacki Okrug, Serbia: 2
Sumadijski Okrug, Serbia: 1
Pontevedra, Spain: 1
Eastern Scotland, United Kingdom: 1
Norfolk, United Kingdom: 1
South Western Scotland, United Kingdom: 1
Connecticut, United States: 1
Florida, United States: 3
Georgia, United States: 1
Kentucky, United States: 1
Maryland, United States: 1
Michigan, United States: 1
New York, United States: 1
North Carolina, United States: 1
Ohio, United States: 2
Texas, United States: 1
Virginia, United States: 1
Wisconsin, United States: 1

Sample of listed locations

Hospital de Niños de la Santísima Trinidad — Córdoba, Córdoba Province, X5014AKM, Argentina — Recruiting
Instituto Médico Río Cuarto — Río Cuarto, Córdoba Province, 5800, Argentina — Recruiting
INECO Neurociencias Oroño — Rosario, Santa Fe Province, S2000DTP, Argentina — Recruiting
Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina — Recruiting
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic — Victoria, British Columbia, V8R 1J8, Canada — Recruiting
Kids Clinic — Ajax, Ontario, L1Z 0M1, Canada — Recruiting
London Health Sciences Centre (LHSC) — London, Ontario, N6A 5W9, Canada — Recruiting
L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret... — Cagliari, South Sardinia, 09121, Italy — Recruiting
Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare — Genoa, 16147, Italy — Recruiting
Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico — Pavia, 27100, Italy — Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To... — Pisa, 56126, Italy — Recruiting
Ospedale Pediatrico Bambino Gesu - Gianicolo — Rome, 00165, Italy — Recruiting
Clinical Research Institute SC-Mexico — Tepetlacolco, 54055, Mexico — Recruiting
AthleticoMed Sp. z o.o. — Bydgoszcz, Kuyavian-Pomerania, 85-752, Poland — Recruiting
Centrum Medyczne Plejady Magdalena Celinska-Lowenhoff, Michal Zolnowski Spolka komandytowa — Krakow, Lesser Poland Voivodeship, 30-363, Poland — Recruiting
Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k — Oświęcim, Lesser Poland Voivodeship, 32-600, Poland — Recruiting
ETG Lublin — Lublin, Lublin Voivodeship, 20-412, Poland — Recruiting
European Trial group network Sp. z o.o - Neuroscience — Warsaw, Masovian Voivodeship, 02-677, Poland — Recruiting
MTZ Clinical Research Powered by PRATIA — Warsaw, Masovian Voivodeship, 02-172, Poland — Recruiting
Hospital de Braga — Braga, 4710-367, Portugal — Recruiting
Hospital Pediátrico de Coimbra — Coimbra, 3000-602, Portugal — Recruiting
Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN) — Porto, 4050, Portugal — Recruiting
Centro Hospitalar Universitario de Sao Joao (CHUSJ) — Porto, 4200-319, Portugal — Recruiting
Univerzitetska Decija Klinika (UDK) (University Children's Hospital) — Belgrade, Beograd, 11000, Serbia — Recruiting
Institute of Child and Youth Health Care of Vojvodina — Novi Sad, Juznobacki Okrug, 21101, Serbia — Recruiting

Study details

Start date: June 8, 2023
Primary completion date: July 6, 2027
Completion date: August 31, 2027
First posted: June 9, 2023

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05897320
Registry last updated: September 9, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT05897320 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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