Clinical trial NCT04965675: A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Migraine in Children
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 285
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Detailed description: The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.

Eligibility criteria: Inclusion Criteria:

* The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
* During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
* During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

Exclusion Criteria:

* The participant has previously been randomised in this study and exposed to eptinezumab.
* The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
* The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit.
* The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).

Primary outcomes:
measure: Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
timeFrame: Baseline, Weeks 1-12
Secondary outcomes:
measure: Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
timeFrame: Baseline up to Weeks 1-12
measure: Percentage of Participants With Migraine on the Day After Dosing (Day 1)
timeFrame: Day 1
measure: Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
timeFrame: Baseline, Weeks 1-12
measure: Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
timeFrame: Baseline up to Weeks 1-12
measure: Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
timeFrame: Baseline up to Weeks 1-4
measure: Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
timeFrame: Baseline up to Weeks 1-4
measure: Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
timeFrame: Baseline, Weeks 1-12
measure: Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
timeFrame: Baseline, Weeks 1-12
measure: Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
timeFrame: Baseline, Weeks 1-12
measure: Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12
timeFrame: Baseline, Weeks 1-12
measure: Free Eptinezumab Plasma Concentration
timeFrame: Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20)
measure: Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
timeFrame: From randomization (Week 0) up to Week 20
measure: Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
timeFrame: From randomization (Week 0) up to Week 20
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Children's Hospital
state: Connecticut
city: Stamford
country: United States
facility: Ki Health Partners LLC DBA New England Institute for Clinical Research
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group, LLC
state: Florida
city: Hialeah
country: United States
facility: A G A Clinical Trials - HyperCore - PPDS
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research
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
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University - Department of Neurology
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health Butterworth Hospital
state: Michigan
city: Amherst
country: United States
facility: Dent Neurosciences Research Center Incorporated
state: New York
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: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center - PIN
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: San Antonio
country: United States
facility: Road Runner Research Ltd
state: Texas
city: Norfolk
country: United States
facility: Children's Specialty Group
state: Virginia
city: Tacoma
country: United States
facility: Mary Bridge Children's Hospital
state: Washington
city: Huntington
country: United States
facility: Marshall University Medical Center
state: West Virginia
city: Mar Del Plata
country: Argentina
facility: Hospital Privado de La Comunidad
state: Buenos Aires
city: Munro
country: Argentina
facility: Clínica Privada Independencia
state: Buenos Aires
city: Ciudad Autónoma Buenos Aires
country: Argentina
facility: Hospital Italiano 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: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Ciudad Autónoma De BuenosAires
city: Ciudad De Cordoba
country: Argentina
facility: Sanatorio Allende S.A
state: Córdoba
city: Córdoba-Barrio Crisol
country: Argentina
facility: Hospital de Niños de La Santisima Trinidad
state: Córdoba
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: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
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: IRCCS Istituto Giannina Gaslini
state: Liguria
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - INCIPIT - PIN
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: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico
state: Puglia
city: Cagliari
country: Italy
facility: AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
state: Sardegna
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
state: Toscana
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
state: Jalisco
city: Zapopan
country: Mexico
facility: Unidad de Investigación en Salud de Chihuahua S.C.
state: Jalisco
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia
state: Michoacán
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina, S.A de C.V
city: Culiacán Sinaloa
country: Mexico
facility: Neurociencias Estudios Clinicos S.C.
city: Durango
country: Mexico
facility: Instituto de Investigationes Clinicas para la Salud A.C.
city: Mexico City
country: Mexico
facility: Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
city: Tepetlacalco
country: Mexico
facility: Clinical Research Institute SC-Mexico
city: Vista Hermosa
country: Mexico
facility: Centro de Estudios Clinicos Y Especialidades Medicas SC
city: Almada
country: Portugal
facility: ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
state: Setúbal
city: Coimbra
country: Portugal
facility: ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
city: Porto
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: 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: Instituto del Sueño
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
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 University Cerrahpasa Medical Faculty Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital NHS Trust
state: Devon
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital - PPDS
state: Lanarkshire
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
state: London, City Of
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: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: