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Study identifier: NCT05789758 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Muscular Atrophy, Spinal  ·  Sponsor: Biogen

PhaseN/A
Planned participants20
Who can joinFemale, 18 Years to 54 Years
Healthy volunteersNo

About this study

In this study, researchers will know more about the effects of nusinersen, also known as Spinraza®, in pregnant participants with spinal muscular atrophy, also known as SMA. This is a drug available for doctors to prescribe for people with SMA. Due to the current treatment options that exist, people with SMA may now reach the age where they can become pregnant. But, there is not enough information known yet about what the effects of nusinersen may be on pregnant people with SMA or on their babies. This is known as an "observational" study, which collects health information about study participants without changing their medical care. The pregnant participants for this study will be found using 3 different groups of SMA study research centers: * ISMAR-US (International SMA Registry in the United States) * UK Adult SMA-REACH (Adult SMA Research and Clinical Hub in the United Kingdom) * SMArtCARE (Austria, Germany, and Switzerland) The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are: * Those who received nusinersen 14 months before the first day of their last period before getting pregnant * Those who received nusinersen 14.5 months before the day they got pregnant * Those who received nusinersen during any time in their pregnancy The main questions researchers want to learn about in this study are: * Loss of pregnancy overall * Loss of pregnancy before the baby was 20 weeks old * Loss of p…

This description comes directly from the study's public registry record.

Talk to the study team

US Biogen Clinical Trial Center  ·  866-633-4636  ·  clinicaltrials@biogen.com

Global Biogen Clinical Trial Center  ·  clinicaltrials@biogen.com

Always discuss trial participation with your own doctor first.

Locations (14)

Stanford Neuroscience Health CenterPalo Alto, California, United StatesRecruiting
Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting
Research SiteCambridge, Massachusetts, United StatesActive Not Recruiting
Columbia University Irving Medical CenterNew York, New York, United StatesRecruiting
University College London Hospitals NHS Foundation TrustLondon, Greater London, United KingdomRecruiting
St George's University NHS Foundation TrustLondon, Greater London, United KingdomRecruiting
The Northern Care Alliance NHS Foundation TrustSalford, Greater Manchester, United KingdomRecruiting
University Hospital Southampton NHS Foundation TrustSouthampton, Hampshire, United KingdomRecruiting
Nottingham University Hospitals TrustNottingham, Nottinghamshire, United KingdomRecruiting
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation TrustOswestry, Shropshire, United KingdomRecruiting
Sheffield Teaching Hospitals NHS Foundation TrustSheffield, South Yorkshire, United KingdomRecruiting
The Newcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon Tyne, Tyne and Wear, United KingdomRecruiting

+ 2 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05789758