Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen (ONWARD)
Muscular Atrophy, Spinal
About this trial
This is an interventional treatment trial for Muscular Atrophy, Spinal
Eligibility Criteria
Key Inclusion Criteria:
- Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the study protocol
Key Exclusion Criteria:
- Treatment with another investigational therapy or enrollment in another interventional clinical study
- Treatment with an approved therapy for SMA after the Day 302 Visit of Study 232SM203 (NCT04089566)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Stanford University Medical Center
- Children's Hospital Colorado
- Ann & Robert H. Lurie Children's Hospital of Chicago
- The Johns Hopkins Hospital
- Boston Children's Hospital
- St. Jude Children's Research Hospital
- Children's Medical Center
- HC-UFMG - Hospital das Clinicas da Universidade Federal de Minas Gerais
- Hospital de Clínicas de Porto Alegre
- Hospital das Clinicas - FMUSP
- London Health Sciences Centre (LHSC) - Children's Hospital
- Hospital Luis Calvo Mackenna
- Clinica Las Condes
- Clinica MEDS La Dehesa
- Guangzhou Woman and Children's Medical Center
- Hospital Universitario San Ignacio
- Fundacion Hospitalaria San Vicente de Paul
- Tallinn Children's Hospital
- Universitaetsklinikum Freiburg
- Universitaetsklinikum Giessen und Marburg GmbH
- Fondazione Serena Onlus - Centro Clinico Nemo
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Kurume University Hospital
- Hyogo Medical University Hospital
- Tokyo Women's Medical University Hospital
- Saint George University Hospital Medical Center
- Instituto Nacional de Pediatria
- Hospital Infantil de Mexico Federico Gomez
- Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
- Instytut 'Pomnik - Centrum Zdrowia Dziecka'
- Regional Pediatric Clinical Hospital #1
- Russian Children Neuromuscular Center of Veltischev
- King Fahad Specialist Hospital
- National Guard Health Affairs: King Abdulaziz Medical City
- King Faisal Specialist Hospital & Research Center
- Hospital Universitario La Paz
- Hospital Universitari i Politecnic La Fe
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
BIIB058 28 mg (Prior Maintenance Dose 28 mg)
BIIB058 50/28 mg (Prior Maintenance Dose 12 mg)
Participants who received maintenance dose of 28 milligram (mg) nusinersen in study 232SM203 (NCT04089566), will receive maintenance dose of 28 mg nusinersen, by intrathecal injection, on Day 1, followed by maintenance dose of 28 mg nusinersen, by intrathecal injection, every 4 months, up to Day 961.
Participants who received maintenance dose of 12 mg nusinersen in study 232SM203 (NCT04089566), will receive loading dose of 50 mg nusinersen, by intrathecal injection, on Day 1, followed by maintenance dose of 28 mg nusinersen, by intrathecal injection, every 4 months, up to Day 961.