A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

Официальное название

Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Eptinezumab
  Concentrate for solution for infusion

Первичные конечные точки

• Number of Participants With Treatment Emergent Adverse Events [Срок оценки: Baseline up to Week 44]

Вторичные конечные точки (4)

• Free Eptinezumab Plasma Concentration [Срок оценки: Baseline, Weeks 8, 12, 24, 36, and 44]
• Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) [Срок оценки: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44]
• Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) [Срок оценки: 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 [Срок оценки: Baseline, Weeks 12, 24, and 36]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Yale University School of Medicine — New Haven
• Ki Health Partners LLC DBA New England Institute for Clinical Research — Stamford
• NW FL Clinical Research Group, LLC — Gulf Breeze
• AGA Clinical Trials - Hialeah - 4980 W 10th Ave — Hialeah
• Axcess Medical Research — Loxahatchee Groves
• University of South Florida — Tampa
• University of Kentucky — Lexington
• University of Maryland School of Medicine — Baltimore
• … и ещё 12 центров

Италия · 8 центров

• IRCCS Ospedale Pediatrico Bambino Gesu — Rome
• IRCCS Istituto Giannina Gaslini — Genoa
• Ospedale San Raffaele S.r.l. — Milan
• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
• 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
• Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia

Польша · 7 центров

• 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

Аргентина · 6 центров

• Hospital Privado de La Comunidad — Mar del Plata
• Hospital de Niños de La Santisima Trinidad — Córdoba-Barrio Crisol
• 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

Португалия · 5 центров

• ULS de Almada-Seixal, EPE - Hospital Garcia de Orta — Almada
• 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
• ULS de São João, EPE - Hospital de São João — Porto

Сербия · 5 центров

• 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

Испания · 5 центров

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

Мексика · 4 центра

• Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C. — Guadalajara
• Clinical Research Institute SC-Mexico — Ampl San Lucas Tepetlacalco
• ICARO Investigaciones en Medicina, S.A de C.V — Chihuahua City
• Instituto de Investigationes Clinicas para la Salud A.C. — Durango

Великобритания · 4 центра

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

Канада · 3 центра

• Vancouver Island Health Authority — Victoria
• The Kids Clinic — Ajax
• London Health Sciences Centre -800 Commissioners Rd E — London

Turkey (Türkiye) · 3 центра

• Izmir City Hospital — Bayraklı
• Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi — Eskişehir
• Mersin University Medical Faculty — Mersin

Идентификаторы

NCT: NCT05164172 · 19379A · 2022-502917-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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