A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

Last updated: December 9, 2024
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Oral Facial Pain

Migraine (Adult)

Treatment

Eptinezumab

Placebo

Clinical Study ID

NCT04965675
19356A
2020-001009-22
  • Ages 12-17
  • All Genders

Study Summary

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant has a diagnosis of migraine (with or without aura) as defined byInternational Classification of Headache Disorders 3 (ICHD-3) guidelines withhistory of chronic migraine, of at least 6 months prior to the screening visit.

  • During the 28-day screening period, the participant must adequately complete theheadache eDiary on at least 23 of the 28 days following the screening visit.

  • During the 28-day screening period, the participant must have ≥15 to ≤26 headachedays, of which at least 8 are migraine days as documented in the eDiary.

Exclusion

Exclusion Criteria:

  • The participant has previously been randomised in this study and exposed toeptinezumab.

  • The participant has been exposed to any monoclonal antibody treatment (includingexposure in a study) <6 months prior to the screening visit.

  • The participant has been exposed to another calcitonin gene-related peptide (CGRP)antibody (including exposure in a study investigating a CGRP antibody) <6 monthsprior to the screening visit.

  • The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicraniacontinua, new daily persistent headache, or unusual migraine subtypes such ashemiplegic migraine (sporadic and familial), migraine with brainstem aura,ophthalmoplegic migraine, or migraine with neurological accompaniments that are nottypical of migraine aura (diplopia, altered consciousness, or long duration; forexample >60 minutes).

Study Design

Total Participants: 285
Treatment Group(s): 2
Primary Treatment: Eptinezumab
Phase: 3
Study Start date:
June 30, 2021
Estimated Completion Date:
March 31, 2026

Study Description

The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.

Connect with a study center

  • Hospital Privado de La Comunidad

    Mar Del Plata, Buenos Aires 7603
    Argentina

    Active - Recruiting

  • Clinica Privada Independencia

    Munro, Buenos Aires 1605
    Argentina

    Active - Recruiting

  • Clínica Privada Independencia

    Munro, Buenos Aires 1605
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma De BuenosAires C1181ACH
    Argentina

    Completed

  • 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

    Active - Recruiting

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires C1280
    Argentina

    Site Not Available

  • Sanatorio Allende S.A

    Ciudad De Cordoba, Cordoba X5000JHGQ
    Argentina

    Completed

  • Sanatorio Allende S.A.

    Ciudad De Cordoba, Cordoba X5000JHGQ
    Argentina

    Active - Recruiting

  • Hospital de Niños de La Santisima Trinidad

    Cordoba-Barrio Crisol, Cordoba X5014AKM
    Argentina

    Active - Recruiting

  • Instituto Médico Río Cuarto

    Río Cuarto, Cordoba 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

  • University of Alberta

    Edmonton, Alberta T6G 2R7
    Canada

    Active - Recruiting

  • Medical Arts Health Research Group - Penticton

    Penticton, British Columbia V2A 5L5
    Canada

    Completed

  • 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

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù IRCCS

    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

    Milano, Lombardia 20133
    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

  • Ospedale San Raffaele S.r.l. - PPDS

    Milano, Lombardia
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Consorziale Policlinico

    Bari, Puglia 70124
    Italy

    Completed

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, Puglia 70124
    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

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

    Guadalajara, Jalisco 44700
    Mexico

    Active - Recruiting

  • Unidad de Investigacion en Salud de Chihuahua S.C.

    Zapopan, Jalisco 45150
    Mexico

    Active - Recruiting

  • Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia

    Morelia, Michoacan 58260
    Mexico

    Active - Recruiting

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

    Chihuahua, 31000
    Mexico

    Active - Recruiting

  • Neurociencias Estudios Clinicos S.C.

    Culiacan Sinaloa, 80020
    Mexico

    Active - Recruiting

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

    Durango, 34000
    Mexico

    Active - Recruiting

  • Unidad de Investigacion en Salud de Chihuahua S.C.-Mexico city

    Mexico City, 14050
    Mexico

    Active - Recruiting

  • Unidad de Investigacion en Salud de Chihuahua S.C.-Renato Leduc 151

    Mexico City, 14050
    Mexico

    Active - Recruiting

  • Clinical Research Institute

    Tepetlacalco, 54055
    Mexico

    Active - Recruiting

  • Clinical Research Institute SC-Mexico

    Tepetlacalco, 54055
    Mexico

    Active - Recruiting

  • Centro de Estudios Clinicos Y Especialidades Medicas SC

    Vista Hermosa, 64620
    Mexico

    Active - Recruiting

  • Hospital Garcia de Orta

    Almada, Setúbal 2805-267
    Portugal

    Active - Recruiting

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

    Almada, Setúbal 2805-267
    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

  • Centro Hospitalar de São João, E.P.E.

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • ULS de São João, EPE - Hospital de São João

    Porto, 4200-319
    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

  • Children and Youth Health Care Institute of Vojvodina

    Novi Sad, 21 000
    Serbia

    Active - Recruiting

  • Clinical Centre 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

  • Instituto de Investigaciones del Sueño

    Madrid, 28036
    Spain

    Completed

  • Instituto del Sueño

    Madrid, 28036
    Spain

    Completed

  • Hospital Universitario Virgen del Rocio - PPDS

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

  • Izmir City Hospital

    Bayrakli, Izmir 35540
    Turkey

    Active - Recruiting

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

    Eskisehir, 26480
    Turkey

    Active - Recruiting

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    Fatih/Istanbul, 34096
    Turkey

    Active - Recruiting

  • Mersin University Medical Faculty

    Mersin, 33169
    Turkey

    Active - Recruiting

  • Royal Devon and Exeter Hospital NHS Trust

    Exeter, Devon EX2 5DW
    United Kingdom

    Completed

  • Queen Elizabeth University Hospital - PPDS

    Glasgow, Lanarkshire G51 4TF
    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

  • Yale-New Haven Children's Hospital

    New Haven, Connecticut 06504-8901
    United States

    Active - Recruiting

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

    Stamford, Connecticut 06905-1206
    United States

    Active - Recruiting

  • Children's National Medical Center

    Washington, District of Columbia 20010-2916
    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 33012-3407
    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 HealthCare (UKHC) Kentucky Clinic

    Lexington, Kentucky 40508-1683
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore, Maryland 21201
    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

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Corewell Health Butterworth Hospital

    Grand Rapids, Michigan 49503-2560
    United States

    Active - Recruiting

  • Spectrum Health Hospitals

    Grand Rapids, Michigan 49503-2560
    United States

    Active - Recruiting

  • Dent Neurosciences Research Center Incorporated

    Amherst, New York 14226-1746
    United States

    Completed

  • North Suffolk Neurology-Commack

    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 28226-8371
    United States

    Active - Recruiting

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

    Charlotte, North Carolina 28211-5027
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center - PIN

    Cincinnati, Ohio 45229-3026
    United States

    Active - Recruiting

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Completed

  • Road Runner Research Ltd

    San Antonio, Texas 78249-3539
    United States

    Active - Recruiting

  • Children's Specialty Group

    Norfolk, Virginia 23510-1021
    United States

    Active - Recruiting

  • Children's Specialty Group - 850 Southampton Ave

    Norfolk, Virginia 23510-1021
    United States

    Active - Recruiting

  • Mary Bridge Children's Hospital

    Tacoma, Washington 98405-4048
    United States

    Completed

  • Marshall University Medical Center

    Huntington, West Virginia 25701-3656
    United States

    Active - Recruiting

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