Actively Recruiting
Study to Evaluate the Efficacy and Safety of Intravenous Eptinezumab in Children and Adolescents With Episodic Migraine
Led by H. Lundbeck A/S · Updated on 2026-03-12
315
Participants Needed
65
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether eptinezumab can reduce the number of migraine days in children and adolescents aged 6 to 17 years with episodic migraine. The study is a randomized, double-blind, placebo-controlled trial designed to assess the preventive effects and safety of intravenous eptinezumab in this pediatric population. It is sponsored by H. Lundbeck A/S and is conducted as a Phase 3 trial. Participants will be randomly assigned to receive one of three treatments: a single weight-adjusted intravenous infusion of eptinezumab 300 mg, a single infusion of eptinezumab 100 mg, or a placebo infusion. The study compares these groups over the course of 12 weeks following the infusion to evaluate changes in migraine frequency and other related outcomes. During the study, participants and their caregivers will complete headache diaries to track migraine and headache days. Researchers will monitor changes in monthly migraine days averaged over weeks 1 to 12 as the primary outcome. Secondary measures include response rates at various thresholds, headache severity, medication use, and migraine disability scores. Blood samples will be collected at several time points to measure drug levels and immune response. The total participation includes baseline screening and 12 weeks of follow-up after the single infusion treatment.
CONDITIONS
Brief Title
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of migraine (with or without aura) according to International Classification of Headache Disorders, 3rd edition
- History of migraine headaches for at least 6 months prior to screening
- Completion of headache diary for at least 23 of 28 days during screening
- At least 14 headache days in the 28-day screening period
- At least 4 migraine days documented during the 28-day screening period
- Age between 6 and 17 years at enrollment
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
- History of moderate or severe head trauma or other neurological or systemic medical disorders affecting the central nervous system
- Current uncontrolled or untreated psychiatric condition for at least 6 months prior to screening
- Lifetime history of psychosis or mania
- Any other disorder requiring treatment that takes priority over migraine or could interfere with study treatment or compliance
- Other exclusion criteria as determined by the investigator
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.
1 visit (in-person)
Duration - 12 weeks
Participants receive a single intravenous infusion of eptinezumab or placebo to evaluate its efficacy and safety for episodic migraine.
1 baseline visit and periodic follow-up visits through Week 12
Duration - 8 weeks
Participants are monitored for safety and antibody responses after treatment completion.
Visits at Weeks 8, 12, and 20 post-dose
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
Research Team
E
Email contact via H. Lundbeck A/S
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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