Actively Recruiting
Spinraza (Nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries
Led by Biogen · Updated on 2026-03-09
20
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand the effects of nusinersen (Spinraza4), a drug prescribed for spinal muscular atrophy (SMA), on pregnant individuals with SMA and their babies. As treatment options allow people with SMA to reach pregnancy age, this observational study collects health information without changing medical care. The study compares pregnancy and birth outcomes among those exposed to nusinersen before or during pregnancy and those without SMA who haven't received nusinersen. Participants include pregnant people with SMA from three SMA registries across different countries. The study observes those exposed to nusinersen within 14 months before the last menstrual period before conception, 14.5 months before conception, or anytime during pregnancy. Data is collected through registries, following participants until 3 months after delivery and their babies up to 2 years after birth. Participants provide health information each trimester, with doctors also contacted during pregnancy and after birth. Baby health is tracked at various ages up to two years. The study measures pregnancy losses, live births, birth defects, infant growth, and maternal and infant deaths up to 10 years. The overall study lasts at least 10 years from the first participant's enrollment.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently pregnant or was pregnant during the relevant exposure window
- Enrolled in the ISMAR registry in the US, UK Adult SMA REACH, or SMArtCARE registry in Germany, Austria, or Switzerland
- Genetic confirmation of spinal muscular atrophy linked to chromosome 5q
- Documentation of exposure to nusinersen up to 14 months before last menstrual period, 14.5 months before conception, or at any time during pregnancy
You will not qualify if you...
- Treatment with risdiplam from two weeks before conception or at any time during pregnancy
- Plans to receive risdiplam treatment during pregnancy
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment and registry enrollment
Duration - Up to 3 months post-delivery for participants; infants followed up to 2 years post-delivery
Participants who are pregnant and exposed to nusinersen are observed prospectively for pregnancy complications and outcomes up to 3 months after delivery. Infants born to these participants are followed for their health and development up to 2 years post-delivery.
Periodic visits or contacts as per registry follow-up schedules
Trial Site Locations
Total: 14 locations
1
Stanford Neuroscience Health Center
Palo Alto, California, United States, 94304
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Research Site
Cambridge, Massachusetts, United States, 02142
Active, Not Recruiting
4
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
5
University College London Hospitals NHS Foundation Trust
London, Greater London, United Kingdom, NW1 2PG
Actively Recruiting
6
St George's University NHS Foundation Trust
London, Greater London, United Kingdom, SW17 0QT
Actively Recruiting
7
The Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester, United Kingdom, M6 8HD
Actively Recruiting
8
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
9
Nottingham University Hospitals Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Actively Recruiting
10
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, United Kingdom, SY10 7AG
Actively Recruiting
11
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S10 2SB
Actively Recruiting
12
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7ND
Actively Recruiting
13
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2GW
Actively Recruiting
14
North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
Research Team
U
US Biogen Clinical Trial Center
G
Global Biogen Clinical Trial Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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