Actively Recruiting

Age: 18Years - 54Years
FEMALE
NCT05789758

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

Led by Biogen · Updated on 2026-03-09

20

Participants Needed

14

Research Sites

515 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 pregnancy after the baby becomes 20 weeks old * Live births * Loss of the baby after birth * Babies who have problems in their body that develop during pregnancy * Babies who are small for their age while in the participant's uterus * Pregnancy that happens outside of the uterus * How many participants die during pregnancy, while the baby is being born, and up to 12 weeks after delivering the baby * Babies who develop problems in their body after birth Researchers will also compare this information to people without SMA who have not received nusinersen. This study will be done as follows: * Information will start being collected when the participant decides to join the study. * Participants will be contacted at each trimester (about every 3 months) to learn about their health and pregnancy. * Participants' doctors will be contacted at each trimester, when the participants are about 6 or 7 months pregnant, and about 4 weeks after the delivery of the baby. * The babies' doctors will be contacted when the baby is 1, 2, 6, 12, 18, and 24 months old. * Each participant will be in the study until the end of their pregnancy and for up to 12 weeks after delivery. Each baby will be in the study for up to 2 years after birth. * The study overall will last at least 10 years from when the first participant joins the study.

CONDITIONS

Official 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

Age: 18Years - 54Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently pregnant or was pregnant during the relevant exposure window and enrolled in ISMAR-US, UK Adult SMA REACH, or SMArtCARE registry
  • Genetic confirmation of spinal muscular atrophy linked to chromosome 5q (5q SMA)
  • Documented exposure to nusinersen up to 14 months before last menstrual period or at any time during pregnancy
Not Eligible

You will not qualify if you...

  • Treatment with risdiplam from 2 weeks before conception or plans to receive risdiplam during pregnancy
  • Treatment with risdiplam at any time from last menstrual period through pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

U

US Biogen Clinical Trial Center

CONTACT

G

Global Biogen Clinical Trial Center

CONTACT

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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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 | DecenTrialz