A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
- Registration Number
- NCT05897320
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 315
- Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
- During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
- During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.
- History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min).
- History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
- Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
- Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.
Other inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive a single IV infusion of matching placebo to eptinezumab. Eptinezumab 100 mg Eptinezumab Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted). Eptinezumab 300 mg Eptinezumab Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
- Primary Outcome Measures
Name Time Method Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 Baseline, Weeks 1-12
- Secondary Outcome Measures
Name Time Method Change From Baseline in Rate of Migraines with Severe Pain Intensity Baseline, Weeks 1-12 Percentage of Participants with Migraine on the Day After Dosing (Day 1) On Day After Dosing Response: ≥50% Reduction From Baseline in MMDs Baseline, Weeks 1-4 and Weeks 1-12 Change From Baseline in MMDs with Acute Medication Use Baseline, Weeks 1-12 Change From Baseline in the Number of Monthly Headache Days (MHDs) Baseline, Weeks 1-12 Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb) Day 0 (pre-dose) and at Weeks 8, 12, and 20 Response: ≥75% reduction from baseline in MMDs Baseline, Weeks 1-4 and Weeks 1-12 Change From Baseline in Monthly Hours with Headache Baseline, Weeks 1-12 Free Eptinezumab Plasma Concentrations Day 0 (pre-dose) and at Weeks 8, 12, and 20 Change From Baseline in Days with Acute Medication Baseline, Weeks 1-12 Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) Day 0 (pre-dose) and at Weeks 8, 12, and 20 Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score Baseline, Week 12
Trial Locations
- Locations (54)
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
🇹🇷Fatih/Istanbul, Turkey
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Clinical Centre of Vojvodina
🇷🇸Novi Sad, Serbia
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
London Health Sciences Centre -800 Commissioners Rd E
🇨🇦London, Ontario, Canada
Clinical Research Institute SC-Mexico
🇲🇽Tepetlacalco, Mexico
Royal Hospital for Children and Young People
🇬🇧Edinburgh, Midlothian, United Kingdom
Ki Health Partners LLC DBA New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Child Neurology of NW Florida
🇺🇸Gulf Breeze, Florida, United States
A G A Clinical Trials - HyperCore - PPDS
🇺🇸Hialeah, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Kentucky HealthCare (UKHC) Kentucky Clinic
🇺🇸Lexington, Kentucky, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
North Suffolk Neurology-Commack
🇺🇸Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
🇺🇸Charlotte, North Carolina, United States
Childrens Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center - PIN
🇺🇸Cincinnati, Ohio, United States
Road Runner Research Ltd
🇺🇸San Antonio, Texas, United States
Children's Specialty Group - 3 Commercial Place
🇺🇸Norfolk, Virginia, United States
Childrens Hospital of Wisconsin
🇺🇸New Berlin, Wisconsin, United States
Clínica Privada Independencia
🇦🇷Munro, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Barracas, Ciudad Autónoma De BuenosAires, Argentina
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Expertia S.A- Mautalén Salud e Investigación
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Córdoba, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Centro de Investigaciones Médicas Tucumán - PPDS
🇦🇷San Miguel de Tucuman, Tucumán, Argentina
Hospital de Niños de La Santisima Trinidad
🇦🇷Cordoba, Argentina
The Kids Clinic
🇨🇦Ajax, Ontario, Canada
Medical Arts Health Research Group - Penticton
🇨🇦Penticton, British Columbia, Canada
Vancouver Island Health Authority
🇨🇦Victoria, British Columbia, Canada
Istituto G Gaslini Ospedale Pediatrico IRCCS
🇮🇹Genova, Liguria, Italy
Ospedale Pediatrico Bambino Gesù IRCCS
🇮🇹Roma, Lazio, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
🇮🇹Pavia, Lombardia, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
🇮🇹Firenze, Toscana, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
🇮🇹Pisa, Toscana, Italy
ULS de Santo António, EPE - Centro Materno Infantil Norte
🇵🇹Porto Covo, Setúbal, Portugal
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Centro Clínico Académico, Braga - Hospital de Braga
🇵🇹Braga, Portugal
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
🇵🇹Coimbra, Portugal
Children and Youth Health Care Institute of Vojvodina
🇷🇸Novi Sad, Serbia
Royal Hospital for Children (Glasgow) - PPDS - PIN
🇬🇧Glasgow, Glasgow City, United Kingdom
James Paget University Hospitals NHS Foundation Trust
🇬🇧Great Yarmouth, Norfolk, United Kingdom
Hospital CUF Descobertas
🇵🇹Lisboa, Portugal
University Clinical Center Nis
🇷🇸Nis, Serbia
Mersin Universitesi Tip Fakultesi Hastanesi
🇹🇷Mersin, Turkey
ULS de São João, EPE - Hospital de São João
🇵🇹Porto Covo, Portugal
Childrens University Hospital
🇷🇸Belgrade, Serbia
Izmir City Hospital
🇹🇷Bayraklı, Izmir, Turkey
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
🇹🇷Eskisehir, Turkey