Clinical Trials in Spain / NCT05164172
Recruiting
Phase 3
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
NCT05164172 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Migraine
Investigational drug(s) / intervention(s)
Eptinezumab: Concentrate for solution for infusion
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Number of Participants With Treatment Emergent Adverse Events — Baseline up to Week 44
Trial sites (70)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Ki Health Partners LLC DBA New England Institute for Clinical Research | Stamford | Connecticut | Recruiting |
| NW FL Clinical Research Group, LLC | Gulf Breeze | Florida | Recruiting |
| AGA Clinical Trials - Hialeah - 4980 W 10th Ave | Hialeah | Florida | Recruiting |
| Axcess Medical Research | Loxahatchee Groves | Florida | Completed |
| University of South Florida | Tampa | Florida | Recruiting |
| University of Kentucky | Lexington | Kentucky | Recruiting |
| University of Maryland School of Medicine | Baltimore | Maryland | Recruiting |
| Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan | Completed |
| Michigan State University - Department of Neurology | East Lansing | Michigan | Completed |
| Helen Devos Childrens' Hospital - PIN | Grand Rapids | Michigan | Completed |
| Dent Neurosciences Research Center Incorporated | Amherst | New York | Completed |
| True North Neurology | Commack | New York | Recruiting |
| OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte | Charlotte | North Carolina | Completed |
| Childrens Hospital Medical Center of Akron | Akron | Ohio | Recruiting |
| Cincinnati Children's Hospital Medical Center - PIN | Cincinnati | Ohio | Recruiting |
| Road Runner Research Ltd | San Antonio | Texas | Recruiting |
| Children's Specialty Group - 3 Commercial Place | Norfolk | Virginia | Recruiting |
| Marshall University Medical Center | Huntington | West Virginia | Recruiting |
| Children's Wisconsin - Milwaukee Campus - PIN | Milwaukee | Wisconsin | Recruiting |
| Hospital Privado de La Comunidad | Mar del Plata | Buenos Aires | Completed |
| Hospital de Niños de La Santisima Trinidad | Córdoba-Barrio Crisol | Córdoba Province | Recruiting |
| Instituto Médico Río Cuarto | Río Cuarto | Córdoba Province | Recruiting |
| INECO Neurociencias Oroño | Rosario | Santa Fe Province | Recruiting |
| Centro de Investigaciones Médicas Tucumán - PPDS | San Miguel de Tucumán | Tucumán Province | Recruiting |
| Expertia S.A- Mautalén Salud e Investigación | Buenos Aires | Argentina | Completed |
| Vancouver Island Health Authority | Victoria | British Columbia | Recruiting |
| The Kids Clinic | Ajax | Ontario | Recruiting |
| London Health Sciences Centre -800 Commissioners Rd E | London | Ontario | Recruiting |
| IRCCS Ospedale Pediatrico Bambino Gesu | Rome | Lazio | Recruiting |
| IRCCS Istituto Giannina Gaslini | Genoa | Liguria | Recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Lombardy | Recruiting |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Milan | Lombardy | Completed |
| AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza | Cagliari | Sardinia | Recruiting |
| Azienda Ospedaliero Universitaria A Meyer (Duplicate) | Florence | Tuscany | Recruiting |
| Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara | Pisa | Tuscany | Recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS | Pavia | Italy | Recruiting |
| Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C. | Guadalajara | Jalisco | Recruiting |
| Clinical Research Institute SC-Mexico | Ampl San Lucas Tepetlacalco | State of Mexico | Recruiting |
| ICARO Investigaciones en Medicina, S.A de C.V | Chihuahua City | Mexico | Recruiting |
+ 30 more sites — see the full list on the official registry below.
More H. Lundbeck A/S trials in Spain
A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
Active, not recruiting
Other trials for the same condition
Migraine and Endometriosis: The FEMININE Study
Starting soon
Migraine Attack Pain Phase Prediction Study
Active, not recruiting
BIOMIGA: Results From Magnetic Resonance Imaging
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05164172 on ClinicalTrials.gov ↗ ← All trials in Spain