A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
- Registration Number
- NCT05164172
- Lead Sponsor
- H. Lundbeck A/S
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eptinezumab 300 mg Eptinezumab Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24. Eptinezumab 100 mg Eptinezumab Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events Baseline up to Week 44
- Secondary Outcome Measures
Name Time Method Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36 Baseline, Weeks 12, 24, and 36 Free Eptinezumab Plasma Concentration Baseline, Weeks 8, 12, 24, 36, and 44 Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Trial Locations
- Locations (54)
Children's Wisconsin - Milwaukee Campus
🇺🇸Milwaukee, Wisconsin, United States
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
🇹🇷Eskisehir, Turkey
Ki Health Partners LLC DBA New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
NW FL Clinical Research Group, LLC
🇺🇸Gulf Breeze, Florida, United States
A G A Clinical Trials - HyperCore - PPDS
🇺🇸Hialeah, Florida, United States
Axcess Medical Research
🇺🇸Loxahatchee Groves, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Kentucky
🇺🇸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
Michigan State University - Department of Neurology
🇺🇸East Lansing, Michigan, United States
Helen Devos Childrens' Hospital
🇺🇸Grand Rapids, Michigan, United States
Dent Neurosciences Research Center Incorporated
🇺🇸Amherst, New York, United States
True North Neurology
🇺🇸Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
🇺🇸Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center - PIN
🇺🇸Cincinnati, Ohio, United States
Road Runner Research Ltd
🇺🇸San Antonio, Texas, United States
Marshall University Medical Center
🇺🇸Huntington, West Virginia, United States
Hospital Privado de La Comunidad
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Expertia S.A- Mautalén Salud e Investigación
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Hospital de Niños de La Santisima Trinidad
🇦🇷Córdoba-Barrio Crisol, Córdoba, Argentina
Instituto Médico RÃo Cuarto
🇦🇷RÃo Cuarto, Córdoba, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Centro de Investigaciones Médicas Tucumán - PPDS
🇦🇷San Miguel de Tucuman, Tucumán, Argentina
Vancouver Island Health Authority
🇨🇦Victoria, British Columbia, Canada
The Kids Clinic
🇨🇦Ajax, Ontario, Canada
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
🇮🇹Roma, Lazio, Italy
IRCCS Istituto Giannina Gaslini
🇮🇹Genova, Liguria, Italy
Ospedale San Raffaele S.r.l. - INCIPIT - PIN
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
🇮🇹Cagliari, Sardegna, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
🇮🇹Firenze, Toscana, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
🇮🇹Pisa, Toscana, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
🇮🇹Pavia, Italy
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
🇲🇽Guadalajara, Jalisco, Mexico
Clinical Research Institute SC-Mexico
🇲🇽Ampl San Lucas Tepetlacalco, México, Mexico
ICARO Investigaciones en Medicina, S.A de C.V
🇲🇽Chihuahua, Mexico
Instituto de Investigationes Clinicas para la Salud A.C.
🇲🇽Durango, Mexico
ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
🇵🇹Almada, Setúbal, Portugal
ULS de Santo António, EPE - Centro Materno Infantil Norte
🇵🇹Porto Covo, Setúbal, Portugal
Centro ClÃnico Académico, Braga - Hospital de Braga
🇵🇹Braga, Portugal
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
🇵🇹Coimbra, Portugal
Childrens University Hospital
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
University Clinical Center Nis
🇷🇸Nis, Serbia
Children and Youth Health Care Institute of Vojvodina
🇷🇸Novi Sad, Serbia
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio - PPDS
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Great Ormond Street Hospital
🇬🇧London, London, City Of, United Kingdom
James Paget University Hospitals NHS Foundation Trust
🇬🇧Great Yarmouth, Norfolk, United Kingdom
Queen Elizabeth University Hospital - PPDS
🇬🇧Glasgow, United Kingdom