NCT04965675RecruitingPhase 3
A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 285 (estimated)
- First submitted
- 7 Jul 2021
- Start date
- 30 Jun 2021
- Primary completion date
- 26 Mar 2027
- Lead sponsor
- H. Lundbeck A/S
- Diseases
- Migraine
- NCT number
- NCT04965675
- EU CT number
- 2024-510656-13-00
- EudraCT number
- 2020-001009-22
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 285
- From 30 Jun 2021 to the primary completion date, 26 Mar 2027
- 82 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
- The participant has previously been randomised in this study and exposed to eptinezumab.
- The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
- The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit.
Other
- The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).
Who the study is looking for
- The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
- During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
- During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (82)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires (HIBA) - Centro de Esclerosis Multiple Buenos Aires (CEMBA) 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 Britanico de Buenos Aires (HOB) 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 |
| Sanatorio Allende S.A. Coordinator of this site? Confirm its status | Córdoba | Argentina | Completed |
| Hospital Privado de Comunidad (HPC) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Completed |
| 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 |
| University of Alberta Hospital (UAH) Coordinator of this site? Confirm its status | Edmonton | Canada | Completed |
| 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 | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Active, not recruiting |
| NHS Lothian - Royal Hospital for Children & Young People (RHCYP) Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| Royal Devon and Exeter Hospital NHS Trust - PPDS Coordinator of this site? Confirm its status | Exeter | United Kingdom | Completed |
| NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos... 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 | Completed |
| Azienda Socio Sanitaria Locale N. 8 Di Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Icaro Investigaciones en Medicina S.A. de C.V. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Recruiting |
| Neurociencias Estudios Clinicos S.C. Coordinator of this site? Confirm its status | Culiacán | Mexico | Completed |
| Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C) Coordinator of this site? Confirm its status | Durango | Mexico | Recruiting |
| Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA) Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Unidad de Investigación en Salud de Chihuahua S.C. Coordinator of this site? Confirm its status | México | Mexico | Completed |
| Centro de Estudios Clinicos y Especialidades Medicas SC Coordinator of this site? Confirm its status | Monterrey | Mexico | Completed |
| 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 |
| Unidad de Investigación en Salud de Chihuahua S.C. Coordinator of this site? Confirm its status | Zapopan | Mexico | Completed |
| Athleticomed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| ETG Lublin Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Oswiecim | Poland | Active, not recruiting |
| ETG Neuroscience Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak Coordinator of this site? Confirm its status | Wrocław | Poland | Active, not recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Active, not recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Active, not recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not 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 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 |
| Dent Neurosciences Research Center Coordinator of this site? Confirm its status | Amherst | United States | Completed |
| 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 - Marlene and Stewart Greenebaum Cancer Center 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 |
| Sarkis Clinical Trials - Gainsville Coordinator of this site? Confirm its status | Gainesville | United States | Completed |
| Corewell Health - Butterworth Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Completed |
| NW FL Clinical Research Group, LLC 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 |
| Marshall Health-Marshall University Medical Center Coordinator of this site? Confirm its status | Huntington | United States | Recruiting |
| UK HealthCare-Kentucky Clinic Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Axcess Medical Research - Loxahatchee Coordinator of this site? Confirm its status | Loxahatchee Groves | United States | Completed |
| Yale-New Haven Children's Hospital Coordinator of this site? Confirm its status | New Haven | United States | Completed |
| Children's Specialty Group (CSG) Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Completed |
| 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 |
| MultiCare Mary Bridge Children's Hospital and Health Center Coordinator of this site? Confirm its status | Tacoma | United States | Completed |
| University of South Florida (USF) - Tampa Campus Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Children's National Hospital - Children's National Heart Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Completed |
| Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital) Coordinator of this site? Confirm its status | Eskişehir | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi - Cerrahpasa Tip Fakultesi (Cerrahpasa Medical Faculty) Coordinator of this site? Confirm its status | Fatih | Turkey (Türkiye) | Completed |
| 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.