155
Participants
Start Date
May 27, 2020
Primary Completion Date
April 23, 2021
Study Completion Date
April 23, 2021
Nusinersen Injectable Product
The patient´s treatment is provided by SUS. The following dosage scheme of nurinersen is the one approved by ANVISA (Brazilian National Health Surveillance Agency): Nusinersen, 12 mg (5 mL) on days 0 (zero), 14 and 28. A fourth dose will be on day 63 with a maintenance dose once every 4 (four) months. The study will NOT have direct influence on the care received by patients. Data on adherence, interventions, hospitalizations, mechanical ventilation, procedures and adverse events will be obtained from the patients´ medical records.
Universidade Federal de Minas Gerais - Hospital das Clínicas, Belo Horizonte
Hospital de Clínicas da Universidade Estadual de Campinas - Unicamp, Campinas
Associação Hospitalar de Prot Infancia Dr Raul Carneiro - Hospital Infantil Pequeno Príncipe, Curitiba
Hospital Infantil Dr. Albert Sabin, Fortaleza
Hospital de Clínicas de Porto Alegre, Porto Alegre
Hospital Universitario Pedro Ernesto, Rio de Janeiro
Instituto de Puericultura e Pediatria Martagão Gesteira da Universidade Federal do rio de Janeiro - UFRJ, Rio de Janeiro
Hospital das Clínicas da Faculdade de Medicina de São Paulo - HCFMUSP, São Paulo
Universidade Federal de São Paulo, São Paulo
Ministry of Health, Brazil
OTHER_GOV
Hospital Israelita Albert Einstein
OTHER