A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

April 19, 2021

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Muscular Atrophy, Spinal
Interventions
DRUG

Nusinersen

Administered as specified in the treatment arm

Trial Locations (39)

100

National Taiwan University Hospital, Taipei

168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

4530

Instituto Nacional de Pediatria, Mexico City

6720

Hospital Infantil de Mexico Federico Gomez, Mexico City

8950

Hospital Sant Joan de Deu, Esplugues Del Llobregat

11211

King Faisal Specialist Hospital & Research Center, Riyadh

13419

Tallinn Children's Hospital, Tallinn

20162

Fondazione Serena Onlus - Centro Clinico Nemo, Milan

21205

The Johns Hopkins Hospital, Baltimore

21423

National Guard Health Affairs: King Abdulaziz Medical City, Jeddah

28046

Hospital Universitario La Paz, Madrid

31444

King Fahad Specialist Hospital, Dammam

35392

Universitaetsklinikum Giessen und Marburg GmbH, Giessen

38105

St. Jude Children's Research Hospital, Memphis

44280

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

46026

Hospital Universitari i Politecnic La Fe, Valencia

75024

Children's Medical Center, Plano

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80045

Children's Hospital Colorado, Aurora

94304

Stanford University Medical Center, Sacramento

100034

Peking University First Hospital, Beijing

110231

Hospital Universitario San Ignacio, Bogotá

125412

Russian Children Neuromuscular Center of Veltischev, Moskva

310052

The Children's Hospital of Zhejiang University School of Medicine, Hangzhou

510623

Guangzhou Woman and Children's Medical Center, Guangzhou

620149

Regional Pediatric Clinical Hospital #1, Yekaterinburg

5403900

Hospital das Clinicas - FMUSP, São Paulo

7500539

Hospital Luis Calvo Mackenna, Santiago

7550000

Clinica Las Condes, Santiago

7691236

Clinica MEDS La Dehesa, Santiago

60611-260

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

02115

Boston Children's Hospital, Boston

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

N6A 5W9

London Health Sciences Centre (LHSC) - Children's Hospital, London

830-0011

Kurume University Hospital, Kurume-shi

663-8501

Hyogo Medical University Hospital, Nishinomiya-shi

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

11 00 2807

Saint George University Hospital Medical Center, Beirut

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY

NCT04729907 - A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD) | Biotech Hunter | Biotech Hunter