Clinical trial NCT05897320: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Episodic Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 315
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
timeFrame: Baseline, Weeks 1-12
Secondary outcomes:
measure: Response: ≥50% Reduction From Baseline in MMDs
timeFrame: Baseline, Weeks 1-4 and Weeks 1-12
measure: Percentage of Participants with Migraine on the Day After Dosing (Day 1)
timeFrame: On Day After Dosing
measure: Change From Baseline in MMDs with Acute Medication Use
timeFrame: Baseline, Weeks 1-12
measure: Response: ≥75% reduction from baseline in MMDs
timeFrame: Baseline, Weeks 1-4 and Weeks 1-12
measure: Change From Baseline in the Number of Monthly Headache Days (MHDs)
timeFrame: Baseline, Weeks 1-12
measure: Change From Baseline in Monthly Hours with Headache
timeFrame: Baseline, Weeks 1-12
measure: Change From Baseline in Days with Acute Medication
timeFrame: Baseline, Weeks 1-12
measure: Change From Baseline in Rate of Migraines with Severe Pain Intensity
timeFrame: Baseline, Weeks 1-12
measure: Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score
timeFrame: Baseline, Week 12
measure: Free Eptinezumab Plasma Concentrations
timeFrame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
measure: Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
timeFrame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
measure: Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)
timeFrame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Ki Health Partners LLC DBA New England Institute for Clinical Research
state: Connecticut
city: Gulf Breeze
country: United States
facility: Child Neurology of NW Florida
state: Florida
city: Hialeah
country: United States
facility: A G A Clinical Trials - HyperCore - PPDS
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Lexington
country: United States
facility: University of Kentucky HealthCare (UKHC) Kentucky Clinic
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Commack
country: United States
facility: North Suffolk Neurology-Commack
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
state: North Carolina
city: Akron
country: United States
facility: Childrens Hospital Medical Center of Akron
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center - PIN
state: Ohio
city: San Antonio
country: United States
facility: Road Runner Research Ltd
state: Texas
city: Norfolk
country: United States
facility: Children's Specialty Group - 3 Commercial Place
state: Virginia
city: New Berlin
country: United States
facility: Childrens Hospital of Wisconsin
state: Wisconsin
city: Munro
country: Argentina
facility: Clínica Privada Independencia
state: Buenos Aires
city: Barracas
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Ciudad Autónoma De BuenosAires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Expertia S.A- Mautalén Salud e Investigación
state: Ciudad Autónoma De BuenosAires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucumán - PPDS
state: Tucumán
city: Cordoba
country: Argentina
facility: Hospital de Niños de La Santisima Trinidad
city: Penticton
country: Canada
facility: Medical Arts Health Research Group - Penticton
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: Ajax
country: Canada
facility: The Kids Clinic
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre -800 Commissioners Rd E
state: Ontario
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù IRCCS
state: Lazio
city: Genova
country: Italy
facility: Istituto G Gaslini Ospedale Pediatrico IRCCS
state: Liguria
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
state: Toscana
city: Tepetlacalco
country: Mexico
facility: Clinical Research Institute SC-Mexico
city: Porto Covo
country: Portugal
facility: ULS de Santo António, EPE - Centro Materno Infantil Norte
state: Setúbal
city: Braga
country: Portugal
facility: Centro Clínico Académico, Braga - Hospital de Braga
city: Coimbra
country: Portugal
facility: ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Porto Covo
country: Portugal
facility: ULS de São João, EPE - Hospital de São João
city: Belgrade
country: Serbia
facility: Childrens University Hospital
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Novi Sad
country: Serbia
facility: Children and Youth Health Care Institute of Vojvodina
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Bayraklı
country: Turkey
facility: Izmir City Hospital
state: Izmir
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
city: Fatih/Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Children (Glasgow) - PPDS - PIN
state: Glasgow City
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Children and Young People
state: Midlothian
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
state: Norfolk
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: