A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
NCT ID: NCT05897320
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
315 participants
INTERVENTIONAL
2023-06-08
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Eptinezumab 300 mg
Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
Eptinezumab
Solution for infusion
Placebo
Participants will receive a single IV infusion of matching placebo to eptinezumab.
Placebo
Solution for infusion
Eptinezumab 100 mg
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Eptinezumab
Solution for infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eptinezumab
Solution for infusion
Placebo
Solution for infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
6 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
H. Lundbeck A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
Child Neurology of NW Florida
Gulf Breeze, Florida, United States
A G A Clinical Trials
Hialeah, 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 School of Medicine
Baltimore, Maryland, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
North Suffolk Neurology-Commack
Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte, North Carolina, United States
Childrens Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States
Road Runner Research Ltd
San Antonio, Texas, United States
Children's Specialty Group - 3 Commercial Place
Norfolk, Virginia, United States
Childrens Hospital of Wisconsin
New Berlin, Wisconsin, United States
Clínica Privada Independencia
Munro, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Barracas, Ciudad Autónoma de BuenosAires, Argentina
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires, Ciudad Autónoma de BuenosAires, 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
Hospital de Niños de La Santisima Trinidad
Córdoba, , Argentina
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
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, Lazio, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS
Genoa, Liguria, Italy
Ospedale San Raffaele S.r.l. - PPDS
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
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, Tuscany, Italy
Clinical Research Institute SC-Mexico
Tepetlacolco, , 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 Santo António, EPE - Centro Materno Infantil Norte
Porto Covo, Setúbal District, Portugal
Centro Clínico Académico, Braga - Hospital de Braga
Braga, , Portugal
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, , Portugal
Hospital CUF Descobertas
Lisbon, , Portugal
ULS de São João, EPE - Hospital de São João
Porto Covo, , Portugal
Childrens University Hospital
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
University Clinical Center Nis
Niš, , 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
Hospital Clinico San Carlos
Madrid, , 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 Universitesi Istanbul Tip Fakultesi Hastanesi
Fatih/Istanbul, , Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, , Turkey (Türkiye)
Royal Hospital for Children (Glasgow) - PPDS - PIN
Glasgow, Glasgow City, 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
Great Ormond Street Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-502538-14-00
Identifier Type: OTHER
Identifier Source: secondary_id
19357A
Identifier Type: -
Identifier Source: org_study_id