A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
Recruiting · NCT04965675 · 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
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.
Who can take part
Age range
12 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
- 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.
Exclusion criteria
- 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.
- 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).
Where it is running
60 locations listed across 15 US states.
- Yale-New Haven Children's Hospital - PIN - New Haven, Connecticut, United States
- Ki Health Partners LLC DBA New England Institute for Clinical Research - Stamford, Connecticut, United States
- Children's National Medical Center - Washington D.C., District of Columbia, United States
- Sarkis Clinical Trials - Gainesville - Gainesville, Florida, United States
- NW FL Clinical Research Group, LLC - Gulf Breeze, Florida, United States
- AGA Clinical Trials - Hialeah - 4980 W 10th Ave - Hialeah, Florida, United States
- Axcess Medical Research - Loxahatchee - Loxahatchee Groves, Florida, United States
- University of South Florida - 13330 USF Laurel Dr - Tampa, Florida, United States
- Clinical Integrative Research Center of Atlanta (CIRCAtl) - Atlanta, Georgia, United States
- University of Kentucky HealthCare (UKHC) Kentucky Clinic - Lexington, Kentucky, United States
- University of Maryland-Marlene and Stewart Greenebaum Cancer Center - Baltimore, Maryland, United States
- Michigan Head Pain and Neurological Institute - Ann Arbor, Michigan, United States
- Corewell Health - Butterworth Hospital - Grand Rapids, Michigan, United States
- Dent Neurosciences Research Center Incorporated - Amherst, New York, United States
- North Suffolk Neurology-Commack - Commack, New York, United States
- OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - Charlotte, North Carolina, United States
- Cincinnati Children's Hospital Medical Center - PIN - Cincinnati, Ohio, United States
- The University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma, United States
- Road Runner Research Ltd - San Antonio, Texas, United States
- Children's Specialty Group (CSG) - Norfolk, Virginia, United States
- Mary Bridge Children's Hospital - PIN - Tacoma, Washington, United States
- Marshall Health-Marshall University Medical Center - Huntington, West Virginia, United States
- Hospital Universitario Vall d'Hebron - PPDS - Barcelona, Spain
- Childrens University Hospital - Belgrade, Serbia
- Expertia S.A- Mautalén Salud e Investigación - Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires (HIBA) - Centro de Esclerosis Multiple Buenos Aires (CEMBA) - Buenos Aires, Argentina
- Hospital Britanico de Buenos Aires (HOB) - Buenos Aires, Argentina
- ICARO Investigaciones en Medicina S.A. de C.V. - Chihuahua City, Mexico
- ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra - Coimbra, Portugal
- Instituto de Investigationes Clinicas para la Salud A.C. - Durango, Mexico
- Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi - Eskişehir, Turkey (Türkiye)
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi - Fatih/Istanbul, Turkey (Türkiye)
- Istanbul University Cerrahpasa Medical Faculty Hospital - Fatih/Istanbul, Turkey (Türkiye)
- Istituto Giannina Gaslini IRCCS - Genoa, Italy
- University Clinical Center Kragujevac - Kragujevac, Serbia
- Great Ormond Street Hospital for Children NHS Foundation Trust - London, United Kingdom
- Hospital Clinico San Carlos - Madrid, Spain
- Mersin University Medical Faculty - Mersin, Turkey (Türkiye)
- Children and Youth Health Care Institute of Vojvodina - Novi Sad, Serbia
- Clinical Center of Vojvodina - Clinic of Psychiatry - Novi Sad, Serbia
- ULS de São João, EPE - Hospital de São João - Porto, Portugal
- Hospital Universitario Virgen del Rocio - PPDS - Seville, Spain
- Clinical Research Institute SC-Mexico - Tepetlacolco, Mexico
- University of Alberta Hospital (UAH) - Edmonton, Alberta, Canada
- Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS - Pavia, Apulia, Italy
- Medical Arts Health Research Group - Penticton - PPDS - Penticton, British Columbia, Canada
- Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic - Victoria, British Columbia, Canada
- Hospital Privado de La Comunidad - Mar del Plata, Buenos Aires, Argentina
- Clínica Privada Independencia - Munro, Buenos Aires, Argentina
- Sanatorio Allende S.A. - Córdoba, Cordoba, Argentina, Argentina
- Hospital de Niños de La Santisima Trinidad - Córdoba-Barrio Crisol, Córdoba Province, Argentina
- Instituto Médico Río Cuarto - Río Cuarto, Córdoba Province, Argentina
- Royal Devon and Exeter Hospital NHS Trust - PPDS - Exeter, Devon, United Kingdom
- Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA) - Guadalajara, Jalisco, Mexico
- Unidad de Investigación en Salud de Chihuahua S.C. - Zapopan, Jalisco, Mexico
- AthleticoMed Sp. z o.o. - Bydgoszcz, Kuyavian-Pomerania, Poland
- IRCCS Ospedale Pediatrico Bambino Gesu - Rome, Lazio, Italy
- 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
- Fondazione IRCCS Istituto Neurologico Carlo Besta - Milan, Lombardy, Italy
Showing 60 of 83 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →