A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
Recruiting · NCT05164172 · Interventional (participants receive a specific treatment) · Lead sponsor: H. Lundbeck A/S
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.
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
- \- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.
Exclusion criteria
- The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
- During lead-in Study19356A or Study19357A:
- participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
- the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later.
- the participant had a serum ALT or AST value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.
Where it is running
60 locations listed across 12 US states.
- Yale University School of Medicine - New Haven, Connecticut, United States
- Ki Health Partners LLC DBA New England Institute for Clinical Research - Stamford, Connecticut, 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 Groves, Florida, United States
- University of South Florida - Tampa, Florida, United States
- University of Kentucky - 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
- Michigan State University - Department of Neurology - East Lansing, Michigan, United States
- Helen Devos Childrens' Hospital - PIN - Grand Rapids, Michigan, United States
- Dent Neurosciences Research Center Incorporated - Amherst, New York, United States
- True North Neurology - 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
- Marshall University Medical Center - Huntington, West Virginia, United States
- Children's Wisconsin - Milwaukee Campus - PIN - Milwaukee, Wisconsin, United States
- Hospital Universitario Vall d'Hebron - PPDS - Barcelona, Spain
- Childrens University Hospital - Belgrade, Serbia
- Centro Clínico Académico, Braga - Hospital de Braga - Braga, Portugal
- Expertia S.A- Mautalén Salud e Investigación - 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)
- Queen Elizabeth University Hospital - PPDS - Glasgow, United Kingdom
- University Clinical Center Kragujevac - Kragujevac, Serbia
- Hospital Clinico San Carlos - Madrid, Spain
- Mersin University Medical Faculty - Mersin, Turkey (Türkiye)
- University Clinical Center Nis - Niš, Serbia
- Children and Youth Health Care Institute of Vojvodina - Novi Sad, Serbia
- Clinical Centre of Vojvodina - Novi Sad, Serbia
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS - Pavia, Italy
- ULS de São João, EPE - Hospital de São João - Porto, Portugal
- Hospital Universitario Virgen del Rocio - PPDS - Seville, Spain
- Hospital Universitari i Politecnic La Fe de Valencia - Valencia, Spain
- Vancouver Island Health Authority - Victoria, British Columbia, Canada
- Hospital Privado de La Comunidad - Mar del Plata, Buenos Aires, Argentina
- Hospital de Niños de La Santisima Trinidad - Córdoba-Barrio Crisol, Córdoba Province, Argentina
- Instituto Médico Río Cuarto - Río Cuarto, Córdoba Province, Argentina
- Great Ormond Street Hospital - PPDS - London, Greater London, United Kingdom
- Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C. - Guadalajara, Jalisco, Mexico
- AthleticoMed - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 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
- IRCCS Istituto Giannina Gaslini - Genoa, Liguria, Italy
- Ospedale San Raffaele S.r.l. - Milan, Lombardy, Italy
- Fondazione IRCCS Istituto Neurologico Carlo Besta - Milan, Lombardy, Italy
- MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak - Wroclaw, Lower Silesian Voivodeship, Poland
- ETG Lublin - PPDS - Lublin, Lublin Voivodeship, Poland
- MTZ Clinical Research Powered by PRATIA - PPDS - Warsaw, Masovian Voivodeship, Poland
- ETG Neuroscience - PPDS - Warsaw, Masovian Voivodeship, Poland
- Royal Hospital for Children and Young People - PIN - Edinburgh, Midlothian, United Kingdom
- James Paget University Hospitals NHS Foundation Trust - Great Yarmouth, Norfolk, United Kingdom
- The Kids Clinic - Ajax, Ontario, Canada
- London Health Sciences Centre -800 Commissioners Rd E - London, Ontario, Canada
Showing 60 of 70 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →