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Can a spinal injection safely slow spinal muscular atrophy? a real-world study in korea seeks answers.

NCT ID NCT04317794

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This study tracks the safety and effectiveness of Spinraza (nusinersen) in people with spinal muscular atrophy (SMA) who receive the drug as part of routine care in Korea. Researchers will monitor for side effects and measure changes in motor skills over time. The goal is to see how well the treatment works outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nusinersen (Spinraza), a drug injected into the spinal fluid to treat spinal muscular atrophy
What this could lead to
If successful, this study could confirm that Spinraza is safe and effective for SMA patients in real-world Korean clinics.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Side effects like injection-site reactions or serious adverse events are possible.

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

74 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Feb 2027

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

Participants who are receiving or about to initiate treatment with commercial Spinraza in Korea according to the local marketing authorization (including documentation of SMA diagnosis), agree to the collection and use of data as specified in the protocol, and meet the eligibility criteria.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * Currently receiving or about to initiate treatment with commercial Spinraza in the postmarketing setting * Genetic documentation of 5q-linked SMA Key Exclusion Criteria: * Hypersensitivity to the active substance or any of the excipients of Spinraza * Ongoing participation or participation within 6 months or 5 half-lives of the agent (whichever is longer) of enrollment in other interventional clinical trials for the treatment of SMA * Inability to comply with study requirements 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

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • Chonbuk National University Hospital

    Jeonju, South Korea

  • Chonnam National University Hospital

    Gwangju, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, South Korea

  • Chungnam National University Hospital

    Daejeon, South Korea

  • Korea University Guro Hospital

    Seoul, South Korea

  • Korea university Anam Hospital

    Seoul, South Korea

  • Kyungpook National University Hospital

    Daegu, South Korea

  • Pusan Natioanl University Hospital

    Busan, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, South Korea

  • Samsung Changwon Hospital

    Changwon, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul Natioanl University Hospital

    Seoul, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Yeungnam University Hospital

    Daegu, South Korea

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