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: 62

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 (62)

New England Institute for Clinical Research (NEICR) - Stamford

Stamford, Connecticut, 06905-1206, United States

RECRUITING

Child Neurology Center (CNC) of Northwest Florida

Gulf Breeze, Florida, 32561-4458, United States

RECRUITING

AGA Clinical Trials

Hialeah, Florida, 33012-3407, United States

RECRUITING

University of South Florida (USF) - Tampa Campus

Tampa, Florida, 33620, United States

RECRUITING

Clinical Integrative Research Center of Atlanta (CIRCAtl)

Atlanta, Georgia, 30328-5574, United States

COMPLETED

UK HealthCare-Kentucky Clinic

Lexington, Kentucky, 40536, United States

COMPLETED

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1509, United States

COMPLETED

Michigan Headache & Neurological Institute (MHNI)

Ann Arbor, Michigan, 48104-5131, United States

COMPLETED

True North Neurology - Commack (North Suffolk Neurology)

Commack, New York, 11725-2850, United States

COMPLETED

OnSite Clinical Solutions, LLC - Charlotte

Charlotte, North Carolina, 28210-0106, United States

COMPLETED

Akron Children's Hospital

Akron, Ohio, 44308-1062, United States

RECRUITING

Cincinnati Children's Hospital Medical Center-Burnet Campus

Cincinnati, Ohio, 45229-3026, United States

RECRUITING

Road Runner Research (RRR)

San Antonio, Texas, 78249-3539, United States

RECRUITING

Children's Specialty Group (CSG)

Norfolk, Virginia, 23507, United States

RECRUITING

Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus

Milwaukee, Wisconsin, 53226, United States

RECRUITING

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

Clinica Independencia

Buenos Aires, 1605, Argentina

COMPLETED

Mautalen Salud e Investigacion

Buenos Aires, C1128AAF, Argentina

COMPLETED

Hospital Britanico de Buenos Aires (HOB)

Buenos Aires, C1280AEB, Argentina

COMPLETED

The Medical Arts Health Research Group - Penticton

Penticton, British Columbia, V2A 5C8, Canada

COMPLETED

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

L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...

Cagliari, South Sardinia, 09121, Italy

RECRUITING

Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare

Genoa, 16147, Italy

RECRUITING

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Milan, 20133, Italy

COMPLETED

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

Centro de Investigacion Clinica de Morelia, S.C.

Morelia, Michoacán, 58070, Mexico

COMPLETED

Clinical Research Institute SC-Mexico

Tepetlacolco, 54055, Mexico

RECRUITING

AthleticoMed Sp. z o.o.

Bydgoszcz, Kuyavian-Pomerania, 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

ETG Lublin

Lublin, Lublin Voivodeship, 20-412, Poland

RECRUITING

MTZ Clinical Research Powered by PRATIA

Warsaw, Masovian Voivodeship, 02-172, Poland

RECRUITING

European Trial group network Sp. z o.o - Neuroscience

Warsaw, Masovian Voivodeship, 02-677, Poland

RECRUITING

Hospital de Braga

Braga, 4710-367, Portugal

RECRUITING

Hospital Pediátrico de Coimbra

Coimbra, 3000-602, Portugal

RECRUITING

Hospital CUF Descobertas, S.A.

Lisbon, 1998-018, Portugal

COMPLETED

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

Univerzitetska Decija Klinika (UDK) (University Children's Hospital)

Belgrade, Beograd, 11000, Serbia

RECRUITING

University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic

Novi Sad, Juznobacki Okrug, 21000, Serbia

RECRUITING

Institute of Child and Youth Health Care of Vojvodina

Novi Sad, Juznobacki Okrug, 21101, Serbia

RECRUITING

Clinical Center Kragujevac

Kragujevac, Sumadijski Okrug, 34000, Serbia

RECRUITING

University Clinical Center Nis

Niš, 18 000, Serbia

RECRUITING

Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC)

Vigo, Pontevedra, 36312, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, 46026, Spain

RECRUITING

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)

Eskişehir, 26480, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Izmir Şehir Hastanesi

Izmir, 35540, Turkey (Türkiye)

RECRUITING

Mersin Universitesi-Tip Fakultesi

Mersin, 33343, Turkey (Türkiye)

RECRUITING

NHS Lothian - Royal Hospital for Children & Young People (RHCYP)

Edinburgh, Eastern Scotland, EH16 4TJ, United Kingdom

RECRUITING

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

RECRUITING

NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...

Glasgow, South Western Scotland, G51 4TF, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 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: September 9, 2026

Record last verified: 2026-09

Locations

PL (6); PT (5); AR (7); TU (4); CA (4); ME (2); ES (4); US (15); SE (5); IT (6); GB (4)