Condition: Muscular Atrophy, Spinal · Sponsor: Biogen
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.
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.
| Stanford Neuroscience Health Center | Palo Alto, California, United States | Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Recruiting |
| Research Site | Cambridge, Massachusetts, United States | Active Not Recruiting |
| Columbia University Irving Medical Center | New York, New York, United States | Recruiting |
| University College London Hospitals NHS Foundation Trust | London, Greater London, United Kingdom | Recruiting |
| St George's University NHS Foundation Trust | London, Greater London, United Kingdom | Recruiting |
| The Northern Care Alliance NHS Foundation Trust | Salford, Greater Manchester, United Kingdom | Recruiting |
| University Hospital Southampton NHS Foundation Trust | Southampton, Hampshire, United Kingdom | Recruiting |
| Nottingham University Hospitals Trust | Nottingham, Nottinghamshire, United Kingdom | Recruiting |
| The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Oswestry, Shropshire, United Kingdom | Recruiting |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield, South Yorkshire, United Kingdom | Recruiting |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne, Tyne and Wear, United Kingdom | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05789758