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
Sites (60)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Britanico de Buenos Aires (HOB) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Completed |
| Clinica Independencia Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Completed |
| Mautalen Salud e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Completed |
| Hospital de Niños de la Santísima Trinidad Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Instituto Médico Río Cuarto Coordinator of this site? Confirm its status | Río Cuarto | Argentina | Recruiting |
| INECO Neurociencias Oroño Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Centro de Investigaciones Medicas Tucuman Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Kids Clinic Coordinator of this site? Confirm its status | Ajax | Canada | Recruiting |
| London Health Sciences Centre (LHSC) Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| The Medical Arts Health Research Group - Penticton Coordinator of this site? Confirm its status | Penticton | Canada | Completed |
| Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic Coordinator of this site? Confirm its status | Victoria | Canada | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC) Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| NHS Lothian - Royal Hospital for Children & Young People (RHCYP) Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo... Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| James Paget University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Great Yarmouth | United Kingdom | Recruiting |
| Great Ormond Street Hospital For Children NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret... Coordinator of this site? Confirm its status | Cagliari | Italy | Completed |
| Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To... Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesu - Gianicolo Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Centro de Investigacion Clinica de Morelia, S.C. Coordinator of this site? Confirm its status | Morelia | Mexico | Completed |
| Clinical Research Institute SC-Mexico Coordinator of this site? Confirm its status | Tepetlacolco | Mexico | Recruiting |
| Centrum Medyczne Plejady Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| ETG Lublin Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. Coordinator of this site? Confirm its status | Oświęcim | Poland | Recruiting |
| European Trial group network Sp. z o.o - Neuroscience Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Hospital de Braga Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Hospital Pediátrico de Coimbra Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Hospital Cuf Descobertas S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Centro Hospitalar Universitario de Sao Joao (CHUSJ) Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN) Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Univerzitetska Decija Klinika (UDK) (University Children's Hospital) Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Clinical Center Kragujevac Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| University Clinical Center NIS Coordinator of this site? Confirm its status | Niš | Serbia | Recruiting |
| University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic Coordinator of this site? Confirm its status | Novi Sad | Serbia | Recruiting |
| Institute of Child and Youth Health Care of Vojvodina Coordinator of this site? Confirm its status | Novi Sad | Serbia | Recruiting |
| Akron Children's Hospital Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| Michigan Headache & Neurological Institute (MHNI) Coordinator of this site? Confirm its status | Ann Arbor | United States | Completed |
| Clinical Integrative Research Center of Atlanta (CIRCAtl) Coordinator of this site? Confirm its status | Atlanta | United States | Completed |
| University of Maryland School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Completed |
| OnSite Clinical Solutions, LLC - Charlotte Coordinator of this site? Confirm its status | Charlotte | United States | Completed |
| Cincinnati Children's Hospital Medical Center-Burnet Campus Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| True North Neurology - Commack (North Suffolk Neurology) Coordinator of this site? Confirm its status | Commack | United States | Completed |
| Child Neurology Center (CNC) of Northwest Florida Coordinator of this site? Confirm its status | Gulf Breeze | United States | Recruiting |
| AGA Clinical Trials Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| UK HealthCare-Kentucky Clinic Coordinator of this site? Confirm its status | Lexington | United States | Completed |
| Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Children's Specialty Group (CSG) Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| Road Runner Research (RRR) Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| New England Institute for Clinical Research (NEICR) - Stamford Coordinator of this site? Confirm its status | Stamford | United States | Recruiting |
| University of South Florida (USF) - Tampa Campus Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital) Coordinator of this site? Confirm its status | Eskişehir | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| İzmir Şehir Hastanesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
| Mersin Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Mersin | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.