A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Last updated: April 10, 2025
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Migraine (Adult)

Migraine (Pediatric)

Oral Facial Pain

Treatment

Eptinezumab

Placebo

Clinical Study ID

NCT05897320
19357A
2022-502538-14-00
  • Ages 6-17
  • All Genders

Study Summary

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of migraine (with or without aura) according to the InternationalClassification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of theinvestigator) with history of migraine headaches of at least 6 months prior to theScreening Visit.

  • During the 28-day screening period, the participant (and their parent/caregiver,when applicable) must adequately complete the headache eDiary (≥23 of the 28 days)following the day of the Screening Visit.

  • During the 28-day screening period, the participant must have ≤14 headache days, ofwhich at least 4 are migraine days as documented in the eDiary.

Exclusion

Exclusion Criteria:

  • History or diagnosis of chronic tension-type headache, hypnic headache, clusterheadache, hemicrania continua, new daily persistent headache, or unusual migrainesubtypes (previously referred to as complicated migraine), such as hemiplegicmigraine (sporadic and familial), migraine with brainstem aura, recurrent painfulophthalmic neuropathy, or migraine with neurological accompaniments that are nottypical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min).

  • History of moderate or severe head trauma or other neurological disorder or systemicmedical disease that is, in the investigator's opinion, likely to affect thefunctions of the central nervous system.

  • Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history ofpsychosis and/or mania are excluded.

  • Any other disorder for which the treatment takes priority over treatment of migraineor is likely to interfere with study treatment or impair treatment compliance.

Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 315
Treatment Group(s): 2
Primary Treatment: Eptinezumab
Phase: 3
Study Start date:
June 08, 2023
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Clínica Privada Independencia

    Munro, Buenos Aires 1605
    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

  • Hospital Britanico de Buenos Aires

    Barracas, Ciudad Autónoma De BuenosAires C1280AEB
    Argentina

    Active - Recruiting

  • Expertia S.A- Mautalén Salud e Investigación

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

    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

  • London Health Sciences Centre -800 Commissioners Rd E

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Istituto G Gaslini Ospedale Pediatrico IRCCS

    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. - PPDS

    Milano, Lombardia 20132
    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 A Meyer - INCIPIT - PIN

    Firenze, Toscana 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

    Pisa, Toscana 56126
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana-Via Roma 67

    Pisa, Toscana 56126
    Italy

    Active - Recruiting

  • Clinical Research Institute SC-Mexico

    Tepetlacalco, 54055
    Mexico

    Active - Recruiting

  • Centro Materno Infantil do Norte

    Porto Covo, Setúbal 4050-651
    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 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

  • Hospital CUF Descobertas

    Lisboa, 1998-018
    Portugal

    Active - Recruiting

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

    Porto Covo, 4200-319
    Portugal

    Active - Recruiting

  • 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

  • Clinical Centre of Vojvodina

    Novi Sad, 21000
    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 Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

  • Izmir City Hospital

    Bayraklı, Izmir 35540
    Turkey

    Active - Recruiting

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

    Eskisehir, 26480
    Turkey

    Active - Recruiting

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Fatih/Istanbul, 34093
    Turkey

    Active - Recruiting

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33169
    Turkey

    Active - Recruiting

  • Royal Hospital for Children (Glasgow) - PPDS - PIN

    Glasgow, Glasgow City G514TF
    United Kingdom

    Active - Recruiting

  • Royal Hospital for Children and Young People

    Edinburgh, Midlothian EH16 4TJ
    United Kingdom

    Active - Recruiting

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk NR31 6LA
    United Kingdom

    Active - Recruiting

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

    Stamford, Connecticut 06905-1206
    United States

    Active - Recruiting

  • Child Neurology of NW Florida

    Gulf Breeze, Florida 32561-4495
    United States

    Active - Recruiting

  • A G A Clinical Trials - HyperCore - PPDS

    Hialeah, Florida 33012-3407
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • University of Kentucky HealthCare (UKHC) Kentucky Clinic

    Lexington, Kentucky 40508-1683
    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

  • 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 - Randolph Rd - Charlotte - ClinEdge - PPDS

    Charlotte, North Carolina 28211-5027
    United States

    Active - Recruiting

  • Childrens Hospital Medical Center of Akron

    Akron, Ohio 44308-1063
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center - PIN

    Cincinnati, Ohio 45229-3026
    United States

    Active - Recruiting

  • 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 - 3 Commercial Place

    Norfolk, Virginia 23510
    United States

    Active - Recruiting

  • Childrens Hospital of Wisconsin

    New Berlin, Wisconsin 53151-7494
    United States

    Active - Recruiting

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