A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

NCT05897320 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 19357A2022-502538-14-00
• Study Type: interventional
• Target: 315
• Locations: 11 countries
• Sites: 65

Brief Summary

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

Conditions

Episodic Migraine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12

  Baseline, Weeks 1-12

Secondary Outcomes (12)

• Response: ≥50% Reduction From Baseline in MMDs

  Baseline, Weeks 1-4 and Weeks 1-12

• Percentage of Participants with Migraine on the Day After Dosing (Day 1)

  On Day After Dosing

• Change From Baseline in MMDs with Acute Medication Use

  Baseline, Weeks 1-12

• Response: ≥75% reduction from baseline in MMDs

  Baseline, Weeks 1-4 and Weeks 1-12

• Change From Baseline in the Number of Monthly Headache Days (MHDs)

  Baseline, Weeks 1-12

Study Arms (3)

Eptinezumab 300 mg

EXPERIMENTAL

Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).

Drug: Eptinezumab

Placebo

PLACEBO COMPARATOR

Participants will receive a single IV infusion of matching placebo to eptinezumab.

Drug: Placebo

Eptinezumab 100 mg

EXPERIMENTAL

Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

Drug: Eptinezumab

Interventions

Eptinezumab DRUG

Solution for infusion

Eptinezumab 100 mg; Eptinezumab 300 mg

Placebo DRUG

Solution for infusion

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening 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, of which at least 4 are migraine days as documented in the eDiary.

You may not qualify if:

• History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical 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 systemic medical disease that is, in the investigator's opinion, likely to affect the functions 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 of psychosis and/or mania are excluded.
• Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (65)

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, 06905-1206, United States

RECRUITING

Child Neurology of NW Florida

Gulf Breeze, Florida, 32561-4495, United States

RECRUITING

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida, 33012, United States

RECRUITING

University of South Florida - 13330 USF Laurel Dr

Tampa, Florida, 33620, United States

RECRUITING

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, 30328-6191, United States

RECRUITING

University of Kentucky HealthCare (UKHC) Kentucky Clinic

Lexington, Kentucky, 40508-1683, United States

COMPLETED

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1544, United States

RECRUITING

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104-5131, United States

COMPLETED

North Suffolk Neurology-Commack

Commack, New York, 11725-2808, United States

RECRUITING

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

Charlotte, North Carolina, 28211-5027, United States

COMPLETED

Childrens Hospital Medical Center of Akron

Akron, Ohio, 44308-1063, United States

RECRUITING

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio, 45229-3026, United States

RECRUITING

Road Runner Research Ltd

San Antonio, Texas, 78249-3539, United States

RECRUITING

Children's Specialty Group - 3 Commercial Place

Norfolk, Virginia, 23510, United States

RECRUITING

Childrens Hospital of Wisconsin - PIN

New Berlin, Wisconsin, 53151-7494, United States

RECRUITING

Clínica Privada Independencia

Munro, Buenos Aires, 1605, Argentina

COMPLETED

Hospital Britanico de Buenos Aires

Barracas, Ciudad Autónoma de BuenosAires, C1280AEB, Argentina

COMPLETED

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, 5800, Argentina

RECRUITING

INECO Neurociencias Oroño

Rosario, Santa Fe Province, S2000DTP, Argentina

RECRUITING

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

RECRUITING

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, C1128AAF, Argentina

COMPLETED

Hospital de Niños de La Santisima Trinidad

Córdoba, X5000BNB, Argentina

RECRUITING

Medical Arts Health Research Group - Penticton - PPDS

Penticton, British Columbia, V2A 5L5, Canada

COMPLETED

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

RECRUITING

The Kids Clinic

Ajax, Ontario, L1Z 0M1, Canada

RECRUITING

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, N6A 5W9, Canada

RECRUITING

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, Lazio, 00165, Italy

RECRUITING

Istituto G Gaslini Ospedale Pediatrico IRCCS

Genoa, Liguria, 16147, Italy

RECRUITING

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

COMPLETED

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, 27100, Italy

RECRUITING

AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza

Cagliari, Sardinia, 09121, Italy

RECRUITING

Azienda Ospedaliero Universitaria A Meyer (Duplicate)

Florence, Tuscany, 50139, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany, 56126, Italy

RECRUITING

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

Morelia, Michoacán, 58260, Mexico

RECRUITING

Clinical Research Institute SC-Mexico

Tepetlacolco, 54055, Mexico

RECRUITING

AthleticoMed

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland

RECRUITING

Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa

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

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

RECRUITING

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, 20-412, Poland

RECRUITING

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, 02-172, Poland

RECRUITING

ETG Neuroscience - PPDS

Warsaw, Masovian Voivodeship, 02-677, Poland

RECRUITING

ULS de São João, EPE - Hospital de São João

Porto Covo, Porto District, 4200-319, Portugal

RECRUITING

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto Covo, Setúbal District, 4050-651, Portugal

RECRUITING

Centro Clínico Académico, Braga - Hospital de Braga

Braga, 4710-243, Portugal

RECRUITING

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, 3000-602, Portugal

RECRUITING

Hospital CUF Descobertas

Lisbon, 1998-018, Portugal

COMPLETED

Childrens University Hospital

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

University Clinical Center Nis

Niš, 18 000, Serbia

RECRUITING

Children and Youth Health Care Institute of Vojvodina

Novi Sad, 21 000, Serbia

RECRUITING

Clinical Centre of Vojvodina

Novi Sad, 21000, Serbia

RECRUITING

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8025, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

RECRUITING

Izmir City Hospital

Bayraklı, İzmir, 35540, Turkey (Türkiye)

RECRUITING

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, 26480, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Fatih/Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, 33169, Turkey (Türkiye)

RECRUITING

Royal Hospital for Children and Young People - PIN

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

RECRUITING

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

RECRUITING

Royal Hospital for Children (Glasgow) - PPDS - PIN

Glasgow, G514TF, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children

London, WCIN 3JH, United Kingdom

RECRUITING

MeSH Terms

Interventions

eptinezumab

Study Officials

• Email contact via H. Lundbeck A/S

  HQ_Medinfo@Lundbeck.com

  STUDY DIRECTOR

Central Study Contacts

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311; HQ_Medinfo@Lundbeck.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: June 8, 2023
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

PL (7); GB (4); IT (8); ME (2); US (15); SE (5); PT (5); ES (4); AR (7); TU (4); CA (4)