A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Recruiting · NCT05897320 · Interventional (participants receive a specific treatment) · Lead sponsor: H. Lundbeck A/S
View the official record on ClinicalTrials.gov →Interventions studied
EptinezumabPlacebo
What this trial is about
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Who can take part
Age range
6 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
- ther inclusion and exclusion criteria may apply.
Where it is running
60 locations listed across 12 US states.
- New England Institute for Clinical Research (NEICR) - Stamford - Stamford, Connecticut, United States
- Child Neurology Center (CNC) of Northwest Florida - Gulf Breeze, Florida, United States
- AGA Clinical Trials - Hialeah, Florida, United States
- University of South Florida (USF) - Tampa Campus - Tampa, Florida, United States
- Clinical Integrative Research Center of Atlanta (CIRCAtl) - Atlanta, Georgia, United States
- UK HealthCare-Kentucky Clinic - Lexington, Kentucky, United States
- University of Maryland School of Medicine - Baltimore, Maryland, United States
- Michigan Headache & Neurological Institute (MHNI) - Ann Arbor, Michigan, United States
- True North Neurology - Commack (North Suffolk Neurology) - Commack, New York, United States
- OnSite Clinical Solutions, LLC - Charlotte - Charlotte, North Carolina, United States
- Akron Children's Hospital - Akron, Ohio, United States
- Cincinnati Children's Hospital Medical Center-Burnet Campus - Cincinnati, Ohio, United States
- Road Runner Research (RRR) - San Antonio, Texas, United States
- Children's Specialty Group (CSG) - Norfolk, Virginia, United States
- Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus - Milwaukee, Wisconsin, United States
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Hospital de Braga - Braga, Portugal
- Clinica Independencia - Buenos Aires, Argentina
- Mautalen Salud e Investigacion - Buenos Aires, Argentina
- Hospital Britanico de Buenos Aires (HOB) - Buenos Aires, Argentina
- Hospital Pediátrico de Coimbra - Coimbra, Portugal
- Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital) - Eskişehir, Turkey (Türkiye)
- Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare - Genoa, Italy
- Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi - Istanbul, Turkey (Türkiye)
- Izmir Şehir Hastanesi - Izmir, Turkey (Türkiye)
- Hospital CUF Descobertas, S.A. - Lisbon, Portugal
- Great Ormond Street Hospital for Children NHS Foundation Trust - London, United Kingdom
- Hospital Clinico San Carlos - Madrid, Spain
- Mersin Universitesi-Tip Fakultesi - Mersin, Turkey (Türkiye)
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta - Milan, Italy
- University Clinical Center Nis - Niš, Serbia
- Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico - Pavia, Italy
- Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To... - Pisa, Italy
- Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN) - Porto, Portugal
- Centro Hospitalar Universitario de Sao Joao (CHUSJ) - Porto, Portugal
- Ospedale Pediatrico Bambino Gesu - Gianicolo - Rome, Italy
- Clinical Research Institute SC-Mexico - Tepetlacolco, Mexico
- Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) - Valencia, Spain
- Univerzitetska Decija Klinika (UDK) (University Children's Hospital) - Belgrade, Beograd, Serbia
- The Medical Arts Health Research Group - Penticton - Penticton, British Columbia, Canada
- Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic - Victoria, British Columbia, Canada
- Hospital de Niños de la Santísima Trinidad - Córdoba, Córdoba Province, Argentina
- Instituto Médico Río Cuarto - Río Cuarto, Córdoba Province, Argentina
- NHS Lothian - Royal Hospital for Children & Young People (RHCYP) - Edinburgh, Eastern Scotland, United Kingdom
- University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic - Novi Sad, Juznobacki Okrug, Serbia
- Institute of Child and Youth Health Care of Vojvodina - Novi Sad, Juznobacki Okrug, Serbia
- AthleticoMed Sp. z o.o. - Bydgoszcz, Kuyavian-Pomerania, Poland
- Centrum Medyczne Plejady Magdalena Celinska-Lowenhoff, Michal Zolnowski Spolka komandytowa - Krakow, Lesser Poland Voivodeship, Poland
- Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k - Oświęcim, Lesser Poland Voivodeship, Poland
- ETG Lublin - Lublin, Lublin Voivodeship, Poland
- MTZ Clinical Research Powered by PRATIA - Warsaw, Masovian Voivodeship, Poland
- European Trial group network Sp. z o.o - Neuroscience - Warsaw, Masovian Voivodeship, Poland
- Centro de Investigacion Clinica de Morelia, S.C. - Morelia, Michoacán, Mexico
- James Paget University Hospitals NHS Foundation Trust - Great Yarmouth, Norfolk, United Kingdom
- Kids Clinic - Ajax, Ontario, Canada
- London Health Sciences Centre (LHSC) - London, Ontario, Canada
- Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC) - Vigo, Pontevedra, Spain
- INECO Neurociencias Oroño - Rosario, Santa Fe Province, Argentina
- L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret... - Cagliari, South Sardinia, Italy
- NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo... - Glasgow, South Western Scotland, United Kingdom
Showing 60 of 62 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →