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)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Non randomized · Quadruple · Treatment
Enrollment
115actual
Sites
39
Countries
Brazil, Canada, Chile +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-04-19 | actual | When the study began enrolling |
| Primary completion | 2026-07-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-30 | actual | The whole study's end, after follow-up |
| First posted | 2021-01-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Muscular Atrophy, Spinal
Intervention
- Drug: Nusinersen — also filed as BIIB058, Spinraza
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured Up to Day 1921
Change from Baseline in Growth Parameters
measured Up to Day 1921
Number of Participants With Shifts from Baseline in Clinical Laboratory Parameters
measured Up to Day 1921
Number of Participants With Shifts from Baseline in Electrocardiogram (ECG)
measured Up to Day 1921
Number of Participants With Shifts from Baseline in Vital Signs
measured Up to Day 1921
Change from Baseline in Activated Partial Thromboplastin Time (aPTT)
measured Up to Day 1921
Change from Baseline in Prothrombin Time (PT)
measured Up to Day 1921
Change from Baseline in International Normalized Ratio (INR)
measured Up to Day 1921
Change from Baseline in Urine Total Protein
measured Up to Day 1921
Change from Baseline in Neurological Examination Outcomes for Participants ≤2 Years of Age
measured Up to Day 1921
Number of Participants with Change from Baseline in Neurological Examination Outcomes for Participants >2 Years of Age
measured Up to Day 1921
Percentage of Participants With a Postbaseline Platelet Count Below the Lower Limit of Normal on at least 2 Consecutive Measurements
measured Up to Day 1921
Percentage of Participants With a Postbaseline Corrected QT Interval Using Fridericia's Formula (QTcF) of >500 millisecond (msec) and an Increase from Baseline to Any Postbaseline Timepoint in QTcF of >60 msec
measured Up toDay 1921
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