A Study to Learn How Nusinersen (Spinraza) Affects Participants With Spinal Muscular Atrophy (SMA) Who Took it Before or During Pregnancy And About The Health of Their Babies
← catalyst calendarNCT05789758 · readout in 2,265 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
20estimated
Sites
14
Countries
United Kingdom, United States
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 | 2023-12-15 | actual | When the study began enrolling |
| Primary completion | 2032-10-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2023-03-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-09 | 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
- Other: No Intervention
Primary outcomes
what the primary-completion date above is the date OFNumber of Pregnancy Terminations
measured Up to 10 years
Number of Spontaneous Abortions
measured Up to 10 years
Number of Fetal Deaths
measured Up to 10 years
Number of Live Births
measured Up to 10 years
Number of Neonatal, Perinatal, and Infant Deaths
measured Up to 10 years
Number of Major Congenital Malformations (MCMs)
measured Up to 10 years
Number of Infants Small for Gestational Age Birth
measured Up to 10 years
Number of Ectopic and Molar Pregnancies
measured Up to 10 years
Number of Maternal Deaths
measured Up to 10 years
Number of Infants With Abnormal Postnatal Growth and Development and Neurobehavioral Impairment
measured Up to 10 years
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