Clinical trial NCT05164172: A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
Official title: Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 600
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 the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

Detailed description: This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine \[CM\] study in adolescents) or 19357A (episodic migraine \[EM\] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.

Eligibility criteria: Inclusion Criteria:

- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

Exclusion Criteria:

* The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
* During lead-in Study19356A or Study19357A:
* participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
* the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later.
* the participant had a serum ALT or AST value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: Baseline up to Week 44
Secondary outcomes:
measure: Free Eptinezumab Plasma Concentration
timeFrame: Baseline, Weeks 8, 12, 24, 36, and 44
measure: Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
timeFrame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
measure: Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
timeFrame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
measure: Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36
timeFrame: Baseline, Weeks 12, 24, and 36
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: 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
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: East Lansing
country: United States
facility: Michigan State University - Department of Neurology
state: Michigan
city: Grand Rapids
country: United States
facility: Helen Devos Childrens' Hospital
state: Michigan
city: Amherst
country: United States
facility: Dent Neurosciences Research Center Incorporated
state: New York
city: Commack
country: United States
facility: True North Neurology
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: San Antonio
country: United States
facility: Road Runner Research Ltd
state: Texas
city: Huntington
country: United States
facility: Marshall University Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Children's Wisconsin - Milwaukee Campus
state: Wisconsin
city: Mar Del Plata
country: Argentina
facility: Hospital Privado de La Comunidad
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Expertia S.A- Mautalén Salud e Investigación
state: Ciudad Autónoma De BuenosAires
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: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: Ajax
country: Canada
facility: The Kids Clinic
state: Ontario
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
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: 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: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
state: Toscana
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
state: Jalisco
city: Ampl San Lucas Tepetlacalco
country: Mexico
facility: Clinical Research Institute SC-Mexico
state: México
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina, S.A de C.V
city: Durango
country: Mexico
facility: Instituto de Investigationes Clinicas para la Salud A.C.
city: Almada
country: Portugal
facility: ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
state: Setúbal
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: 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: 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: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
state: London, City Of
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
state: Norfolk
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital - PPDS
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: