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

NCT05164172 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 19379A2022-502917-27-00
• Study Type: interventional
• Target: 600
• Locations: 11 countries
• Sites: 70

Brief 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  Baseline up to Week 44

Secondary Outcomes (4)

• Free Eptinezumab Plasma Concentration

  Baseline, Weeks 8, 12, 24, 36, and 44

• Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])

  Baseline (Week 0), Weeks 8, 12, 24, 36, and 44

• Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

  Baseline (Week 0), Weeks 8, 12, 24, 36, and 44

• Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36

  Baseline, Weeks 12, 24, and 36

Study Arms (2)

Eptinezumab 300 mg

EXPERIMENTAL

Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.

Drug: Eptinezumab

Eptinezumab 100 mg

EXPERIMENTAL

Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.

Drug: Eptinezumab

Interventions

Eptinezumab DRUG

Concentrate for solution for infusion

Also known as: Vyepti

Eptinezumab 100 mg; Eptinezumab 300 mg

Eligibility Criteria

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

You may qualify if:

• \- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

You may not qualify if:

• The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
• During lead-in Study19356A or Study19357A:
• participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
• the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later.
• the participant had a serum ALT or AST value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (70)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

RECRUITING

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, 06905-1206, United States

RECRUITING

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, 32561-4458, United States

RECRUITING

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida, 33012, United States

RECRUITING

Axcess Medical Research

Loxahatchee Groves, Florida, 33470-9272, United States

COMPLETED

University of South Florida

Tampa, Florida, 33612-6601, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536-7001, United States

RECRUITING

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

Michigan State University - Department of Neurology

East Lansing, Michigan, 48824-7015, United States

COMPLETED

Helen Devos Childrens' Hospital - PIN

Grand Rapids, Michigan, 49503-2528, United States

RECRUITING

Dent Neurosciences Research Center Incorporated

Amherst, New York, 14226-1727, United States

COMPLETED

True North Neurology

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

Marshall University Medical Center

Huntington, West Virginia, 25701-3656, United States

RECRUITING

Children's Wisconsin - Milwaukee Campus - PIN

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Hospital Privado de La Comunidad

Mar del Plata, Buenos Aires, 7603, Argentina

COMPLETED

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, C1128AAF, Argentina

COMPLETED

Hospital de Niños de La Santisima Trinidad

Córdoba-Barrio Crisol, 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 Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

RECRUITING

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

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Rome, Lazio, 00165, Italy

RECRUITING

IRCCS Istituto Giannina Gaslini

Genoa, Liguria, 16147, Italy

RECRUITING

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

Milan, Lombardy, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

COMPLETED

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

Cagliari, Sardinia, 09121, Italy

RECRUITING

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Florence, Tuscany, 50139, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany, 56126, Italy

RECRUITING

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, 27100, Italy

RECRUITING

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

Guadalajara, Jalisco, 44700, Mexico

RECRUITING

Clinical Research Institute SC-Mexico

Ampl San Lucas Tepetlacalco, México, 54055, Mexico

RECRUITING

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

Chihuahua City, 31000, Mexico

RECRUITING

Instituto de Investigationes Clinicas para la Salud A.C.

Durango, 34000, 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 Almada-Seixal, EPE - Hospital Garcia de Orta

Almada, Setúbal District, 2805-267, 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

ULS de São João, EPE - Hospital de São João

Porto, 4200-319, Portugal

RECRUITING

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, 21 000, 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 Universitario Virgen del Rocio - PPDS

Seville, 41013, 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

Mersin University Medical Faculty

Mersin, 33169, Turkey (Türkiye)

RECRUITING

Great Ormond Street Hospital - PPDS

London, London, City of, WC1N 3JH, United Kingdom

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

Queen Elizabeth University Hospital - PPDS

Glasgow, G514TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 20, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (20); ME (4); GB (4); TU (3); IT (8); ES (5); AR (6); PL (7); PT (5); CA (3); SE (5)