Actively Recruiting
Long-term, Open-label Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine
Led by H. Lundbeck A/S · Updated on 2026-04-15
600
Participants Needed
70
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of eptinezumab in children and adolescents aged 6 to 17 years who have chronic or episodic migraine. This phase 3 open-label extension study includes participants who completed prior studies focused on chronic or episodic migraine treatment. The goal is to monitor safety outcomes over an extended period to better understand the effects of eptinezumab in this younger population. Participants will receive eptinezumab by intravenous infusion in one of two weight-adjusted dose groups: 100 mg or 300 mg. Those who were previously assigned to a dose in the lead-in study will continue with the same dose, while those who received placebo will be randomly assigned to either dose group. Infusions are given at Weeks 0, 12, and 24 during the study. During the study, participants will be monitored through various assessments including blood tests for eptinezumab levels and antibodies, and a Pediatric Migraine Disability Assessment Questionnaire at multiple timepoints. Safety will be tracked from baseline up to Week 44 by recording any treatment emergent adverse events. The study lasts over several months, with follow-ups scheduled through Week 44 to evaluate long-term safety and impact on migraine-related disability.
CONDITIONS
Brief Title
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant must have completed Week 12 visit of either Study 19356A (chronic migraine) or Study 19357A (episodic migraine) immediately before enrolling in this extension study.
You will not qualify if you...
- The participant has an adverse event or safety concern related to treatment in the previous study considered a potential safety risk.
- The participant experienced an anaphylactic or other severe hypersensitivity reaction to the study drug infusion during the prior study.
- The participant had liver enzyme (ALT or AST) values over 5 times the upper limit of normal confirmed within 2 weeks.
- The participant had ALT or AST values over 3 times the upper limit of normal with total bilirubin over 2 times the upper limit of normal during the prior study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive intravenous infusions of eptinezumab adjusted to their weight. The treatment includes 3 infusions given at Weeks 0, 12, and 24.
3 IV infusion visits at Weeks 0, 12, and 24, plus additional assessment visits at Weeks 8, 36, and 44
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
Research Team
E
Email contact via H. Lundbeck A/S
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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