Actively Recruiting

Phase 3
Age: 6Years - 17Years
All Genders
NCT05164172

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

Led by H. Lundbeck A/S · Updated on 2026-04-15

600

Participants Needed

70

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The participant must have completed Week 12 (completion) visit of either Study 19356A (chronic migraine) or Study 19357A (episodic migraine) immediately prior to enrollment into this extension study.
Not Eligible

You will not qualify if you...

  • The participant has an adverse event or safety concern related to double-blind treatment in the lead-in study considered a potential safety risk by the investigator.
  • The participant experienced an anaphylactic or other severe hypersensitivity reaction to the investigational medicinal product infusion during the lead-in study.
  • The participant had serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 5 times the upper limit of normal confirmed by testing within 2 weeks during the lead-in study.
  • The participant had serum ALT or AST values greater than 3 times the upper limit of normal and a serum total bilirubin value greater than 2 times the upper limit of normal during the lead-in study.

AI-Screening

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Trial Site Locations

Total: 70 locations

1

Yale University School of Medicine

New Haven, Connecticut, United States, 06511

Actively Recruiting

2

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, United States, 06905-1206

Actively Recruiting

3

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States, 32561-4458

Actively Recruiting

4

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida, United States, 33012

Actively Recruiting

5

Axcess Medical Research

Loxahatchee Groves, Florida, United States, 33470-9272

Completed

6

University of South Florida

Tampa, Florida, United States, 33612-6601

Actively Recruiting

7

University of Kentucky

Lexington, Kentucky, United States, 40536-7001

Actively Recruiting

8

University of Maryland School of Medicine

Baltimore, Maryland, United States, 21201-1544

Actively Recruiting

9

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States, 48104-5131

Completed

10

Michigan State University - Department of Neurology

East Lansing, Michigan, United States, 48824-7015

Completed

11

Helen Devos Childrens' Hospital - PIN

Grand Rapids, Michigan, United States, 49503-2528

Actively Recruiting

12

Dent Neurosciences Research Center Incorporated

Amherst, New York, United States, 14226-1727

Completed

13

True North Neurology

Commack, New York, United States, 11725-2808

Actively Recruiting

14

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

Charlotte, North Carolina, United States, 28211-5027

Completed

15

Childrens Hospital Medical Center of Akron

Akron, Ohio, United States, 44308-1063

Actively Recruiting

16

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio, United States, 45229-3026

Actively Recruiting

17

Road Runner Research Ltd

San Antonio, Texas, United States, 78249-3539

Actively Recruiting

18

Children's Specialty Group - 3 Commercial Place

Norfolk, Virginia, United States, 23510

Actively Recruiting

19

Marshall University Medical Center

Huntington, West Virginia, United States, 25701-3656

Actively Recruiting

20

Children's Wisconsin - Milwaukee Campus - PIN

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

21

Hospital Privado de La Comunidad

Mar del Plata, Buenos Aires, Argentina, 7603

Completed

22

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1128AAF

Completed

23

Hospital de Niños de La Santisima Trinidad

Córdoba-Barrio Crisol, Córdoba Province, Argentina, X5014AKM

Actively Recruiting

24

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina, 5800

Actively Recruiting

25

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina, S2000DTP

Actively Recruiting

26

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL

Actively Recruiting

27

Vancouver Island Health Authority

Victoria, British Columbia, Canada, V8R 1J8

Actively Recruiting

28

The Kids Clinic

Ajax, Ontario, Canada, L1Z 0M1

Actively Recruiting

29

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, Canada, N6A 5W9

Actively Recruiting

30

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Rome, Lazio, Italy, 00165

Actively Recruiting

31

IRCCS Istituto Giannina Gaslini

Genoa, Liguria, Italy, 16147

Actively Recruiting

32

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

Milan, Lombardy, Italy, 20132

Actively Recruiting

33

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy, 20133

Completed

34

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

Cagliari, Sardinia, Italy, 09121

Actively Recruiting

35

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Florence, Tuscany, Italy, 50139

Actively Recruiting

36

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany, Italy, 56126

Actively Recruiting

37

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Italy, 27100

Actively Recruiting

38

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

Guadalajara, Jalisco, Mexico, 44700

Actively Recruiting

39

Clinical Research Institute SC-Mexico

Ampl San Lucas Tepetlacalco, México, Mexico, 54055

Actively Recruiting

40

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

Chihuahua City, Mexico, 31000

Actively Recruiting

41

Instituto de Investigationes Clinicas para la Salud A.C.

Durango, Mexico, 34000

Actively Recruiting

42

AthleticoMed

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

Actively Recruiting

43

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

Krakow, Lesser Poland Voivodeship, Poland, 30-363

Actively Recruiting

44

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

Oświęcim, Lesser Poland Voivodeship, Poland, 32-600

Actively Recruiting

45

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship, Poland, 52-210

Actively Recruiting

46

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, Poland, 20-412

Actively Recruiting

47

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland, 02-172

Actively Recruiting

48

ETG Neuroscience - PPDS

Warsaw, Masovian Voivodeship, Poland, 02-677

Actively Recruiting

49

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

Almada, Setúbal District, Portugal, 2805-267

Actively Recruiting

50

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto Covo, Setúbal District, Portugal, 4050-651

Actively Recruiting

51

Centro Clínico Académico, Braga - Hospital de Braga

Braga, Portugal, 4710-243

Actively Recruiting

52

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, Portugal, 3000-602

Actively Recruiting

53

ULS de São João, EPE - Hospital de São João

Porto, Portugal, 4200-319

Actively Recruiting

54

Childrens University Hospital

Belgrade, Serbia, 11000

Actively Recruiting

55

University Clinical Center Kragujevac

Kragujevac, Serbia, 34000

Actively Recruiting

56

University Clinical Center Nis

Niš, Serbia, 18 000

Actively Recruiting

57

Children and Youth Health Care Institute of Vojvodina

Novi Sad, Serbia, 21 000

Actively Recruiting

58

Clinical Centre of Vojvodina

Novi Sad, Serbia, 21 000

Actively Recruiting

59

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain, 36312

Actively Recruiting

60

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain, 8025

Actively Recruiting

61

Hospital Clinico San Carlos

Madrid, Spain, 28040

Actively Recruiting

62

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain, 41013

Actively Recruiting

63

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain, 46026

Actively Recruiting

64

Izmir City Hospital

Bayraklı, İzmir, Turkey (Türkiye), 35540

Actively Recruiting

65

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, Turkey (Türkiye), 26480

Actively Recruiting

66

Mersin University Medical Faculty

Mersin, Turkey (Türkiye), 33169

Actively Recruiting

67

Great Ormond Street Hospital - PPDS

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

Actively Recruiting

68

Royal Hospital for Children and Young People - PIN

Edinburgh, Midlothian, United Kingdom, EH16 4TJ

Actively Recruiting

69

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, United Kingdom, NR31 6LA

Actively Recruiting

70

Queen Elizabeth University Hospital - PPDS

Glasgow, United Kingdom, G514TF

Actively Recruiting

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Research Team

E

Email contact via H. Lundbeck A/S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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