Actively Recruiting

Phase 3
Age: 12Years - 17Years
All Genders
NCT04965675

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

Led by H. Lundbeck A/S · Updated on 2026-05-13

285

Participants Needed

84

Research Sites

278 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

CONDITIONS

Official Title

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
  • During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
  • During the 28-day screening period, the participant must have 6515 to 6426 headache days, of which at least 8 are migraine days as documented in the eDiary.
Not Eligible

You will not qualify if you...

  • The participant has previously been randomised in this study and exposed to eptinezumab.
  • The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.
  • The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.
  • The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 84 locations

1

Yale-New Haven Children's Hospital - PIN

New Haven, Connecticut, United States, 06504-8901

Actively Recruiting

2

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, United States, 06905-1206

Actively Recruiting

3

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010-2916

Completed

4

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States, 32561-4458

Actively Recruiting

5

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida, United States, 33012

Actively Recruiting

6

Axcess Medical Research

Loxahatchee Groves, Florida, United States, 33470-9272

Completed

7

University of South Florida

Tampa, Florida, United States, 33612-6601

Actively Recruiting

8

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, United States, 30328-6191

Actively Recruiting

9

University of Kentucky HealthCare (UKHC) Kentucky Clinic

Lexington, Kentucky, United States, 40508-1683

Actively Recruiting

10

University of Maryland

Baltimore, Maryland, United States, 21201

Actively Recruiting

11

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States, 48104-5131

Completed

12

Michigan State University - Department of Neurology

East Lansing, Michigan, United States, 48824-7015

Completed

13

Corewell Health Butterworth Hospital

Grand Rapids, Michigan, United States, 49503-2560

Actively Recruiting

14

Dent Neurosciences Research Center Incorporated

Amherst, New York, United States, 14226-1746

Completed

15

North Suffolk Neurology-Commack

Commack, New York, United States, 11725-2808

Actively Recruiting

16

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

Charlotte, North Carolina, United States, 28211-5027

Completed

17

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio, United States, 45229-3026

Actively Recruiting

18

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Completed

19

Road Runner Research Ltd

San Antonio, Texas, United States, 78249-3539

Actively Recruiting

20

Children's Specialty Group

Norfolk, Virginia, United States, 23510-1021

Actively Recruiting

21

Mary Bridge Children's Hospital - PIN

Tacoma, Washington, United States, 98405-4048

Completed

22

Marshall University Medical Center

Huntington, West Virginia, United States, 25701-3656

Actively Recruiting

23

Hospital Privado de La Comunidad

Mar del Plata, Buenos Aires, Argentina, 7603

Completed

24

Clínica Privada Independencia

Munro, Buenos Aires, Argentina, 1605

Completed

25

Hospital Britanico de Buenos Aires

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1280

Completed

26

Hospital Italiano de Buenos Aires

Ciudad Autónoma Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1181ACH

Completed

27

Sanatorio Allende S.A

Córdoba, Córdoba Province, Argentina, X5000JHGQ

Completed

28

Hospital de Niños de La Santisima Trinidad

Córdoba, Córdoba Province, Argentina, X5014AKM

Actively Recruiting

29

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina, 5800

Actively Recruiting

30

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina, S2000DTP

Actively Recruiting

31

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL

Actively Recruiting

32

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Argentina, C1128AAF

Completed

33

University of Alberta

Edmonton, Alberta, Canada, T6G 2R7

Completed

34

Medical Arts Health Research Group - Penticton - PPDS

Penticton, British Columbia, Canada, V2A 5L5

Completed

35

Vancouver Island Health Authority

Victoria, British Columbia, Canada, V8R 1J8

Actively Recruiting

36

The Kids Clinic

Ajax, Ontario, Canada, L1Z 0M1

Actively Recruiting

37

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, Canada, N6A 5W9

Actively Recruiting

38

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Apulia, Italy, 70124

Completed

39

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, Lazio, Italy, 00165

Actively Recruiting

40

IRCCS Istituto Giannina Gaslini

Genoa, Liguria, Italy, 16147

Actively Recruiting

41

Ospedale San Raffaele S.r.l.

Milan, Lombardy, Italy, 20132

Actively Recruiting

42

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy, 20133

Completed

43

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, Italy, 27100

Actively Recruiting

44

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

Cagliari, Sardinia, Italy, 09121

Actively Recruiting

45

Azienda Ospedaliero Universitaria A Meyer (Duplicate)

Florence, Tuscany, Italy, 50139

Actively Recruiting

46

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

Guadalajara, Jalisco, Mexico, 44700

Actively Recruiting

47

Unidad de Investigación en Salud de Chihuahua S.C.

Zapopan, Jalisco, Mexico, 45150

Completed

48

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

Morelia, Michoacán, Mexico, 58260

Actively Recruiting

49

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

Chihuahua City, Mexico, 31000

Actively Recruiting

50

Neurociencias Estudios Clinicos S.C.

Culiacán Sinaloa, Mexico, 80020

Completed

51

Instituto de Investigationes Clinicas para la Salud A.C.

Durango, Mexico, 34000

Actively Recruiting

52

Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city

Mexico City, Mexico, 14050

Completed

53

Clinical Research Institute SC-Mexico

México, Mexico, 54055

Actively Recruiting

54

Centro de Estudios Clinicos Y Especialidades Medicas SC

Monterrey, Mexico, 64620

Completed

55

AthleticoMed

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

Actively Recruiting

56

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

Krakow, Lesser Poland Voivodeship, Poland, 30-363

Actively Recruiting

57

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

Oświęcim, Lesser Poland Voivodeship, Poland, 32-600

Actively Recruiting

58

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship, Poland, 52-210

Actively Recruiting

59

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, Poland, 20-412

Actively Recruiting

60

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland, 02-172

Actively Recruiting

61

ETG Neuroscience - PPDS

Warsaw, Masovian Voivodeship, Poland, 02-677

Actively Recruiting

62

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

Almada, Setúbal District, Portugal, 2805-267

Actively Recruiting

63

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, Portugal, 3000-602

Actively Recruiting

64

ULS de São João, EPE - Hospital de São João

Porto, Portugal, 4200-319

Actively Recruiting

65

Childrens University Hospital

Belgrade, Serbia, 11000

Actively Recruiting

66

University Clinical Center Kragujevac

Kragujevac, Serbia, 34000

Actively Recruiting

67

Children and Youth Health Care Institute of Vojvodina

Novi Sad, Serbia, 21 000

Actively Recruiting

68

Clinical Centre of Vojvodina

Novi Sad, Serbia, 21 000

Actively Recruiting

69

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain, 36213

Actively Recruiting

70

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain, 8025

Actively Recruiting

71

Instituto del Sueño

Madrid, Spain, 28036

Completed

72

Hospital Clinico San Carlos

Madrid, Spain, 28040

Actively Recruiting

73

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain, 41013

Actively Recruiting

74

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain, 46026

Actively Recruiting

75

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, Turkey (Türkiye), 26480

Actively Recruiting

76

Istanbul Üniversitesi, Istanbul Tip Fakültesi, Nör

Fatih/Istanbul, Turkey (Türkiye), 34093

Actively Recruiting

77

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih/Istanbul, Turkey (Türkiye), 34096

Completed

78

Izmir City Hospital

Izmir, Turkey (Türkiye), 35540

Actively Recruiting

79

Mersin University Medical Faculty

Mersin, Turkey (Türkiye), 33169

Actively Recruiting

80

Royal Devon and Exeter Hospital NHS Trust - PPDS

Exeter, Devon, United Kingdom, EX2 5DW

Completed

81

Queen Elizabeth University Hospital - PPDS

Glasgow, Lanarkshire, United Kingdom, G51 4TF

Actively Recruiting

82

Great Ormond Street Hospital - PPDS

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

Actively Recruiting

83

Royal Hospital for Children and Young People - PIN

Edinburgh, Midlothian, United Kingdom, EH16 4TJ

Actively Recruiting

84

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, United Kingdom, NR31 6LA

Actively Recruiting

Loading map...

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

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here