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New study tracks spinraza in pregnancy for SMA moms

NCT ID NCT05789758

Knowledge-focused Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study gathers health information from pregnant women with spinal muscular atrophy (SMA) who have taken the drug Spinraza (nusinersen), and from their babies. Researchers want to learn about pregnancy outcomes, such as miscarriage, birth defects, and infant development. The study is observational, meaning it does not change the medical care participants receive. About 20 women from SMA registries in the US, UK, and Europe will take part, with babies followed for up to 2 years after birth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Oct 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant participants with SMA who are exposed to nusinersen from the UK Adult SMA REACH, ISMAR - US, and SMArtCARE registries will be enrolled to obtain information on effects of nusinersen on pregnancy complications and outcomes.

Ages

18 to 54 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participant who is currently pregnant (or was pregnant during the relevant exposure window) and enrolled in the United States (US) network of the ISMAR registry, the United Kingdom (UK) Adult SMA REACH, or the Germany, Austria, or Switzerland network of the SMArtCARE registry * Genetic documentation of spinal muscular atrophy linked to chromosome 5q (5q SMA) * Documentation that the participant was exposed to nusinersen up to 14 months prior to the first day of their LMP before conception, 14.5 months before conception, and/or at any time during their pregnancy Key Exclusion Criteria: * Treatment with risdiplam at any time from the first day of their LMP, 2 weeks prior to the date of conception (approximately 5 half-lives), and/or plans to receive treatment with risdiplam during pregnancy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

spinal muscular atrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Muscular atrophy, spinal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • North Bristol NHS Trust

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • Nottingham University Hospitals Trust

    RECRUITING

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Research Site

    ACTIVE_NOT_RECRUITING

    Cambridge, Massachusetts, 02142, United States

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, South Yorkshire, S10 2SB, United Kingdom

  • St George's University NHS Foundation Trust

    RECRUITING

    London, Greater London, SW17 0QT, United Kingdom

  • Stanford Neuroscience Health Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle upon Tyne, Tyne and Wear, NE7 7ND, United Kingdom

  • The Northern Care Alliance NHS Foundation Trust

    RECRUITING

    Salford, Greater Manchester, M6 8HD, United Kingdom

  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

    RECRUITING

    Oswestry, Shropshire, SY10 7AG, United Kingdom

  • University College London Hospitals NHS Foundation Trust

    RECRUITING

    London, Greater London, NW1 2PG, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, West Midlands, B15 2GW, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.