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Clinical Trials in the UK / 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 UK tracker
Sponsor
H. Lundbeck A/S
Phase
Phase 3
Started
2021-12-01
Last updated
2026-06-12

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

Eptinezumab

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

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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)

Trial sites (70)

FacilityCityRegionStatus
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 the UK

Other trials for the same condition

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 the UK