Actively Recruiting

Phase 3
Age: 6Years - 17Years
All Genders
NCT05897320

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Led by H. Lundbeck A/S · Updated on 2026-03-12

315

Participants Needed

65

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of migraine (with or without aura) per International Classification of Headache Disorders, 3rd edition, with history of migraine headaches for at least 6 months prior to screening
  • Completion of headache electronic diary for at least 23 of 28 days during screening period
  • At least 14 headache days during the 28-day screening, including 4 or more migraine days
Not Eligible

You will not qualify if you...

  • History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine, migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological symptoms not typical of migraine aura
  • History of moderate or severe head trauma or other neurological or systemic disease affecting the central nervous system
  • Uncontrolled or untreated psychiatric condition for at least 6 months prior to screening; lifetime history of psychosis or mania
  • Any disorder requiring treatment that takes priority over migraine or may interfere with study treatment or compliance
  • Other inclusion and exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 65 locations

1

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, United States, 06905-1206

Actively Recruiting

2

Child Neurology of NW Florida

Gulf Breeze, Florida, United States, 32561-4495

Actively Recruiting

3

AGA Clinical Trials

Hialeah, Florida, United States, 33012

Actively Recruiting

4

University of South Florida - 13330 USF Laurel Dr

Tampa, Florida, United States, 33620

Actively Recruiting

5

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, United States, 30328-6191

Actively Recruiting

6

University of Kentucky HealthCare (UKHC) Kentucky Clinic

Lexington, Kentucky, United States, 40508-1683

Actively Recruiting

7

University of Maryland School of Medicine

Baltimore, Maryland, United States, 21201-1544

Actively Recruiting

8

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States, 48104-5131

Completed

9

North Suffolk Neurology-Commack

Commack, New York, United States, 11725-2808

Actively Recruiting

10

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

Charlotte, North Carolina, United States, 28211-5027

Completed

11

Childrens Hospital Medical Center of Akron

Akron, Ohio, United States, 44308-1063

Actively Recruiting

12

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio, United States, 45229-3026

Actively Recruiting

13

Road Runner Research Ltd

San Antonio, Texas, United States, 78249-3539

Actively Recruiting

14

Children's Specialty Group - 3 Commercial Place

Norfolk, Virginia, United States, 23510

Actively Recruiting

15

Childrens Hospital of Wisconsin - PIN

New Berlin, Wisconsin, United States, 53151-7494

Actively Recruiting

16

Clínica Privada Independencia

Munro, Buenos Aires, Argentina, 1605

Completed

17

Hospital Britanico de Buenos Aires

Barracas, Ciudad Autónoma de BuenosAires, Argentina, C1280AEB

Completed

18

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1128AAF

Completed

19

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina, 5800

Actively Recruiting

20

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina, S2000DTP

Actively Recruiting

21

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL

Actively Recruiting

22

Hospital de Niños de La Santisima Trinidad

Córdoba, Argentina

Actively Recruiting

23

Medical Arts Health Research Group - Penticton - PPDS

Penticton, British Columbia, Canada, V2A 5L5

Completed

24

Vancouver Island Health Authority

Victoria, British Columbia, Canada, V8R 1J8

Actively Recruiting

25

The Kids Clinic

Ajax, Ontario, Canada, L1Z 0M1

Actively Recruiting

26

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, Canada, N6A 5W9

Actively Recruiting

27

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, Lazio, Italy, 00165

Actively Recruiting

28

Istituto G Gaslini Ospedale Pediatrico IRCCS

Genoa, Liguria, Italy, 16147

Actively Recruiting

29

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, Italy, 20132

Actively Recruiting

30

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy, 20133

Completed

31

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, Italy, 27100

Actively Recruiting

32

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

Cagliari, Sardinia, Italy, 09121

Actively Recruiting

33

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Florence, Tuscany, Italy, 50139

Actively Recruiting

34

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara

Pisa, Tuscany, Italy, 56126

Actively Recruiting

35

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

Morelia, Michoacán, Mexico, 58260

Actively Recruiting

36

Clinical Research Institute SC-Mexico

Tepetlacolco, Mexico, 54055

Actively Recruiting

37

AthleticoMed

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

Actively Recruiting

38

ETG Neuroscience - PPDS

Warsaw, Masovian Voivodeship, Poland, 02-677

Actively Recruiting

39

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

Krakow, Poland, 30-363

Actively Recruiting

40

ETG Lublin - PPDS

Lublin, Poland, 20-412

Actively Recruiting

41

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

Oświęcim, Poland, 32-600

Actively Recruiting

42

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Poland, 02-172

Actively Recruiting

43

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Poland, 52-210

Actively Recruiting

44

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto Covo, Setúbal District, Portugal, 4050-651

Actively Recruiting

45

Centro Clínico Académico, Braga - Hospital de Braga

Braga, Portugal, 4710-243

Actively Recruiting

46

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, Portugal, 3000-602

Actively Recruiting

47

Hospital CUF Descobertas

Lisbon, Portugal, 1998-018

Completed

48

ULS de São João, EPE - Hospital de São João

Porto Covo, Portugal, 4200-319

Actively Recruiting

49

Childrens University Hospital

Belgrade, Serbia, 11000

Actively Recruiting

50

University Clinical Center Kragujevac

Kragujevac, Serbia, 34000

Actively Recruiting

51

University Clinical Center Nis

Niš, Serbia, 18 000

Actively Recruiting

52

Children and Youth Health Care Institute of Vojvodina

Novi Sad, Serbia, 21 000

Actively Recruiting

53

Clinical Centre of Vojvodina

Novi Sad, Serbia, 21000

Actively Recruiting

54

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain, 36312

Actively Recruiting

55

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain, 8025

Actively Recruiting

56

Hospital Clinico San Carlos

Madrid, Spain, 28040

Actively Recruiting

57

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain, 46026

Actively Recruiting

58

Izmir City Hospital

Bayraklı, İzmir, Turkey (Türkiye), 35540

Actively Recruiting

59

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, Turkey (Türkiye), 26480

Actively Recruiting

60

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Fatih/Istanbul, Turkey (Türkiye), 34093

Actively Recruiting

61

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, Turkey (Türkiye), 33169

Actively Recruiting

62

Royal Hospital for Children (Glasgow) - PPDS - PIN

Glasgow, Glasgow City, United Kingdom, G514TF

Actively Recruiting

63

Royal Hospital for Children and Young People - PIN

Edinburgh, Midlothian, United Kingdom, EH16 4TJ

Actively Recruiting

64

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, United Kingdom, NR31 6LA

Actively Recruiting

65

Great Ormond Street Hospital

London, United Kingdom, WCIN 3JH

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

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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