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A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

NCT ID: NCT05164172
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: H. Lundbeck A/S
Conditions: Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

Enrollment: 600 participants (Estimated).

What is being studied

Intervention: eptinezumab
Drug: Eptinezumab

Who may be eligible

Ages: 6 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

64 study locations are listed.

Recruiting site status is explicitly provided for 64 locations; 54 are listed as Recruiting.

Countries: Argentina, Canada, Italy, Mexico, Poland, Portugal, Serbia, Spain, Turkey (Türkiye), United Kingdom, United States

Buenos Aires, Argentina: 1
Buenos Aires F.D., Argentina: 1
Córdoba Province, Argentina: 2
Santa Fe Province, Argentina: 1
Tucumán Province, Argentina: 1
British Columbia, Canada: 1
Ontario, Canada: 2
South Sardinia, Italy: 1
Durango, Mexico: 1
Jalisco, Mexico: 1
State of Mexico, Mexico: 1
Lesser Poland Voivodeship, Poland: 2
Lublin Voivodeship, Poland: 1
Masovian Voivodeship, Poland: 2
Setúbal District, Portugal: 1
Beograd, Serbia: 1
Juznobacki Okrug, Serbia: 2
Sumadijski Okrug, Serbia: 1
Seville, Spain: 1
Eastern Scotland, United Kingdom: 1
Norfolk, United Kingdom: 1
South Western Scotland, United Kingdom: 1
Connecticut, United States: 2
Florida, United States: 5
Kentucky, United States: 1
Maryland, United States: 1
Michigan, United States: 2
New York, United States: 2
North Carolina, United States: 1
Ohio, United States: 2

Sample of listed locations

Hospital de Niños de la Santísima Trinidad — Córdoba, Córdoba Province, X5014AKM, Argentina — Recruiting
Instituto Médico Río Cuarto — Río Cuarto, Córdoba Province, 5800, Argentina — Recruiting
INECO Neurociencias Oroño — Rosario, Santa Fe Province, S2000DTP, Argentina — Recruiting
Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina — Recruiting
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic — Victoria, British Columbia, V8R 1J8, Canada — Recruiting
Kids Clinic — Ajax, Ontario, L1Z 0M1, Canada — Recruiting
London Health Sciences Centre (LHSC) — London, Ontario, N6A 5W9, Canada — Recruiting
Istituto Giannina Gaslini IRCCS — Genoa, 16147, Italy — Recruiting
Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico — Pavia, 27100, Italy — Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To... — Pisa, 56126, Italy — Recruiting
Ospedale Pediatrico Bambino Gesu - Gianicolo — Rome, 00165, Italy — Recruiting
Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C) — Durango, Durango, 34000, Mexico — Recruiting
Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA) — Guadalajara, Jalisco, 44130, Mexico — Recruiting
Clinical Research Institute SC-Mexico — Tepetlacalco, State of Mexico, 54055, Mexico — Recruiting
ICARO Investigaciones en Medicina, S.A de C.V — Chihuahua City, 31000, Mexico — Recruiting
Centrum Medyczne Plejady — Krakow, Lesser Poland Voivodeship, 30-363, Poland — Recruiting
Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k — Oświęcim, Lesser Poland Voivodeship, 32-600, Poland — Recruiting
ETG Lublin — Lublin, Lublin Voivodeship, 20-412, Poland — Recruiting
European Trial group network Sp. z o.o - Neuroscience — Warsaw, Masovian Voivodeship, 02-677, Poland — Recruiting
MTZ Clinical Research Powered by PRATIA — Warsaw, Masovian Voivodeship, 02-172, Poland — Recruiting
Unidade Local de Saude de Almada-Seixal E.P.E. (ULSAS) — Almada, Setúbal District, 2805-267, Portugal — Recruiting
Hospital de Braga — Braga, 4710-367, Portugal — Recruiting
Hospital Pediátrico de Coimbra — Coimbra, 3000-602, Portugal — Recruiting
Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN) — Porto, 4050, Portugal — Recruiting
Centro Hospitalar Universitario de Sao Joao (CHUSJ) — Porto, 4200-319, Portugal — Recruiting

Study details

Start date: December 1, 2021
Primary completion date: April 30, 2028
Completion date: April 30, 2028
First posted: December 20, 2021

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05164172
Registry last updated: October 14, 2026
QualifiedStudies registry data refreshed: October 19, 2026
QualifiedStudies record fetched: October 19, 2026

View NCT05164172 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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