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

Last updated: February 12, 2025
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Pain (Pediatric)

Migraine (Adult)

Pain

Treatment

Eptinezumab

Clinical Study ID

NCT05164172
19379A
2022-502917-27-00
2020-001649-38
  • Ages 6-17
  • All Genders

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 Criteria

Inclusion

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

Exclusion Criteria:

  • The participant has an adverse event or other safety concerns that are deemedrelated to double-blind treatment received in the lead-in study and is considered apotential safety risk by the investigator.

  • During lead-in Study19356A or Study19357A:

  • participant experienced ananaphylactic reaction or another severe and/or serioushypersensitivity reaction to the investigational medicinal product (IMP) infusion,as assessed by the investigator

  • the participant had a serum alanine aminotransferase (ALT) or aspartateaminotransferase(AST) value >5 times the upper limit of the reference range that wasconfirmed by testing <2 weeks later.

  • the participant had a serum ALT or AST value >3times the upper limit of thereference range and a serum total bilirubin value >2times the upper limit of thereference range.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Eptinezumab
Phase: 3
Study Start date:
December 01, 2021
Estimated Completion Date:
March 01, 2026

Study Description

This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine [CM] study in adolescents) or 19357A (episodic migraine [EM] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.

Connect with a study center

  • Hospital Privado de La Comunidad

    Mar Del Plata, Buenos Aires 7603
    Argentina

    Active - Recruiting

  • Expertia S.A- Mautalen Salud e Investigacion

    Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires C1128AAF
    Argentina

    Active - Recruiting

  • Expertia S.A- Mautalén Salud e Investigacion

    Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires C1128AAF
    Argentina

    Site Not Available

  • Expertia S.A- Mautalén Salud e Investigación

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1128AAF
    Argentina

    Active - Recruiting

  • Hospital de Niños de La Santisima Trinidad

    Cordoba-Barrio Crisol, Cordoba X5014AKM
    Argentina

    Site Not Available

  • Hospital de Niños de La Santisima Trinidad

    Córdoba-Barrio Crisol, Córdoba X5014AKM
    Argentina

    Active - Recruiting

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba 5800
    Argentina

    Active - Recruiting

  • INECO Neurociencias Orono

    Rosario, Santa Fe S2000DTP
    Argentina

    Active - Recruiting

  • INECO Neurociencias Oroño

    Rosario, Santa Fe S2000DTP
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucuman, Tucuman T4000AXL
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Médicas Tucuman - PPDS

    San Miguel de Tucuman, Tucuman T4000AXL
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Médicas Tucumán - PPDS

    San Miguel de Tucuman, Tucumán T4000AXL
    Argentina

    Active - Recruiting

  • Hospital de Niños de La Santisima Trinidad

    Cordoba,
    Argentina

    Site Not Available

  • Vancouver Island Health Authority

    Victoria, British Columbia V8R 1J8
    Canada

    Active - Recruiting

  • The Kids Clinic

    Ajax, Ontario L1Z 0M1
    Canada

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini

    Genova, Liguria 16147
    Italy

    Active - Recruiting

  • Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico

    Genova, Liguria 16147
    Italy

    Active - Recruiting

  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • Ospedale San Raffaele S.r.l. - INCIPIT - PIN

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN

    Cagliari, Sardegna 09121
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

    Firenze, Toscana 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

    Pisa, Toscana 56126
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, 27100
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, 27100
    Italy

    Active - Recruiting

  • Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.

    Guadalajara, Jalisco 44700
    Mexico

    Active - Recruiting

  • Clinical Research Institute

    Ampl San Lucas Tepetlacalco, México 54055
    Mexico

    Active - Recruiting

  • Clinical Research Institute SC-Mexico

    Ampl San Lucas Tepetlacalco, México 54055
    Mexico

    Active - Recruiting

  • ICARO Investigaciones en Medicina, S.A de C.V

    Chihuahua, 31000
    Mexico

    Active - Recruiting

  • Instituto de Investigationes Clinicas para la Salud A.C.

    Durango, 34000
    Mexico

    Active - Recruiting

  • ULS de Almada-Seixal, EPE - Hospital Garcia de Orta

    Almada, Setúbal 2805-267
    Portugal

    Active - Recruiting

  • ULS de Santo Antonio, EPE - Centro Materno Infantil Norte

    Porto Covo, Setúbal 4050-651
    Portugal

    Active - Recruiting

  • ULS de Santo António, EPE - Centro Materno Infantil Norte

    Porto Covo, Setúbal 4050-651
    Portugal

    Active - Recruiting

  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Hospital Pediatrico de Coimbra

    Coimbra, 3000-602
    Portugal

    Active - Recruiting

  • ULS de Coimbra, EPE - Hospital Pediatrico de Coimbra

    Coimbra, 3000-602
    Portugal

    Active - Recruiting

  • ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

    Coimbra, 3000-602
    Portugal

    Active - Recruiting

  • Childrens University Hospital

    Beograd, Belgrade 11000
    Serbia

    Site Not Available

  • Childrens University Hospital

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • University Clinical Center Nis

    Nis, 18 000
    Serbia

    Active - Recruiting

  • Children and Youth Health Care Institute of Vojvodina

    Novi Sad, 21 000
    Serbia

    Active - Recruiting

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra 36312
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8025
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio - PPDS

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

  • Great Ormond Street Hospital

    London, London, City Of WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital for Children

    London, London, City Of WC1N 3JH
    United Kingdom

    Active - Recruiting

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk NR31 6LA
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth University Hospital - PPDS

    Glasgow, G514TF
    United Kingdom

    Active - Recruiting

  • Ki Health Partners LLC DBA New England Institute for Clinical Research

    Stamford, Connecticut 06905-1206
    United States

    Active - Recruiting

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida 32561-4458
    United States

    Active - Recruiting

  • A G A Clinical Trials - HyperCore - PPDS

    Hialeah, Florida 33012-3402
    United States

    Active - Recruiting

  • Axcess Medical Research

    Loxahatchee Groves, Florida 33470-9272
    United States

    Completed

  • University of South Florida

    Tampa, Florida 33612-6601
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40536-7001
    United States

    Active - Recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201-1544
    United States

    Active - Recruiting

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan 48104-5131
    United States

    Active - Recruiting

  • Michigan State University - Department of Neurology

    East Lansing, Michigan 48824-7015
    United States

    Active - Recruiting

  • Devos Childrens Hospital

    Grand Rapids, Michigan 49503-2528
    United States

    Active - Recruiting

  • Helen DeVos Children Hospital

    Grand Rapids, Michigan 49503-2514
    United States

    Active - Recruiting

  • Helen Devos Childrens' Hospital

    Grand Rapids, Michigan 49503-2528
    United States

    Active - Recruiting

  • Dent Neurosciences Research Center Incorporated

    Amherst, New York 14226-1727
    United States

    Completed

  • North Suffolk Neurology-Commack

    Commack, New York 11725-2808
    United States

    Active - Recruiting

  • True North Neurology

    Commack, New York 11725-2808
    United States

    Active - Recruiting

  • OnSite Clinical Solutions, LLC - Charlotte - ClinEdge - PPDS

    Charlotte, North Carolina 28211-5027
    United States

    Active - Recruiting

  • OnSite Clinical Solutions, LLC - ClinEdge - PPDS

    Charlotte, North Carolina 28226-8380
    United States

    Active - Recruiting

  • OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS

    Charlotte, North Carolina 28211-5027
    United States

    Active - Recruiting

  • Road Runner Research Ltd

    San Antonio, Texas 78249-3539
    United States

    Active - Recruiting

  • Marshall University Medical Center

    Huntington, West Virginia 25701-3656
    United States

    Active - Recruiting

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