A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Official title

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine

Overview

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

Interventions

• Drug Eptinezumab
  Solution for infusion
• Drug Placebo
  Solution for infusion

Primary outcome measures

• Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 [Time frame: Baseline, Weeks 1-12]

Secondary outcome measures (12)

• Response: ≥50% Reduction From Baseline in MMDs [Time frame: Baseline, Weeks 1-4 and Weeks 1-12]
• Percentage of Participants with Migraine on the Day After Dosing (Day 1) [Time frame: On Day After Dosing]
• Change From Baseline in MMDs with Acute Medication Use [Time frame: Baseline, Weeks 1-12]
• Response: ≥75% reduction from baseline in MMDs [Time frame: Baseline, Weeks 1-4 and Weeks 1-12]
• Change From Baseline in the Number of Monthly Headache Days (MHDs) [Time frame: Baseline, Weeks 1-12]
• Change From Baseline in Monthly Hours with Headache [Time frame: Baseline, Weeks 1-12]
• Change From Baseline in Days with Acute Medication [Time frame: Baseline, Weeks 1-12]
• Change From Baseline in Rate of Migraines with Severe Pain Intensity [Time frame: Baseline, Weeks 1-12]
• Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score [Time frame: Baseline, Week 12]
• Free Eptinezumab Plasma Concentrations [Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20]
• Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) [Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20]
• Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb) [Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 15 centers

• Ki Health Partners LLC DBA New England Institute for Clinical Research — Stamford
• Child Neurology of NW Florida — Gulf Breeze
• AGA Clinical Trials - Hialeah - 4980 W 10th Ave — Hialeah
• University of South Florida - 13330 USF Laurel Dr — Tampa
• Clinical Integrative Research Center of Atlanta — Atlanta
• University of Kentucky HealthCare (UKHC) Kentucky Clinic — Lexington
• University of Maryland School of Medicine — Baltimore
• Michigan Head Pain and Neurological Institute — Ann Arbor
• … and 7 more centers

Italy · 8 centers

• Ospedale Pediatrico Bambino Gesù IRCCS — Rome
• Istituto G Gaslini Ospedale Pediatrico IRCCS — Genoa
• Ospedale San Raffaele S.r.l. - PPDS — Milan
• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
• Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia
• AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza — Cagliari
• Azienda Ospedaliero Universitaria A Meyer (Duplicate) — Florence
• Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara — Pisa

Argentina · 7 centers

• Clínica Privada Independencia — Munro
• Hospital Britanico de Buenos Aires — Barracas
• Instituto Médico Río Cuarto — Río Cuarto
• INECO Neurociencias Oroño — Rosario
• Centro de Investigaciones Médicas Tucumán - PPDS — San Miguel de Tucumán
• Expertia S.A- Mautalén Salud e Investigación — Buenos Aires
• Hospital de Niños de La Santisima Trinidad — Córdoba

Poland · 7 centers

• AthleticoMed — Bydgoszcz
• Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandyto — Krakow
• Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. — Oświęcim
• MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak — Wroclaw
• ETG Lublin - PPDS — Lublin
• MTZ Clinical Research Powered by PRATIA - PPDS — Warsaw
• ETG Neuroscience - PPDS — Warsaw

Portugal · 5 centers

• ULS de São João, EPE - Hospital de São João — Porto Covo
• ULS de Santo António, EPE - Centro Materno Infantil Norte — Porto Covo
• Centro Clínico Académico, Braga - Hospital de Braga — Braga
• ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra — Coimbra
• Hospital CUF Descobertas — Lisbon

Serbia · 5 centers

• Childrens University Hospital — Belgrade
• University Clinical Center Kragujevac — Kragujevac
• University Clinical Center Nis — Niš
• Children and Youth Health Care Institute of Vojvodina — Novi Sad
• Clinical Centre of Vojvodina — Novi Sad

Canada · 4 centers

• Medical Arts Health Research Group - Penticton - PPDS — Penticton
• Vancouver Island Health Authority — Victoria
• The Kids Clinic — Ajax
• London Health Sciences Centre -800 Commissioners Rd E — London

Spain · 4 centers

• CHUVI - H.U. Alvaro Cunqueiro — Vigo
• Hospital Universitario Vall d'Hebron - PPDS — Barcelona
• Hospital Clinico San Carlos — Madrid
• Hospital Universitari i Politecnic La Fe de Valencia — Valencia

Turkey (Türkiye) · 4 centers

• Izmir City Hospital — Bayraklı
• Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi — Eskişehir
• Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi — Fatih/Istanbul
• Mersin Universitesi Tip Fakultesi Hastanesi — Mersin

United Kingdom · 4 centers

• Royal Hospital for Children and Young People - PIN — Edinburgh
• James Paget University Hospitals NHS Foundation Trust — Great Yarmouth
• Royal Hospital for Children (Glasgow) - PPDS - PIN — Glasgow
• Great Ormond Street Hospital for Children — London

Mexico · 2 centers

• Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia — Morelia
• Clinical Research Institute SC-Mexico — Tepetlacolco

Identifiers

NCT: NCT05897320 · 19357A · 2022-502538-14-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗