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Search / Trial NCT04317794

Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)

Launched by BIOGEN · Mar 20, 2020

Trial Information

Current as of June 05, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Spinraza (nusinersen sodium) to see how safe and effective it is for people with spinal muscular atrophy (SMA) in Korea. The main goal is to monitor the safety of this treatment after it has been approved for use, and the secondary goal is to assess how well it works for patients. The trial is currently looking for participants of all ages who are either already receiving Spinraza or are about to start treatment and have a specific genetic type of SMA.

To be eligible, participants must have proof of a genetic condition known as 5q-linked SMA. However, individuals who are allergic to Spinraza or who are currently involved in another clinical trial for SMA cannot join this study. Those who participate can expect to help researchers gather important information about the effects and safety of Spinraza in a real-world setting, which could benefit future patients.

Gender

ALL

Eligibility criteria

  • 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.

About Biogen

Biogen is a leading biotechnology company dedicated to discovering, developing, and delivering innovative therapies for neurological and neurodegenerative diseases. With a strong focus on research and development, Biogen leverages advanced science and cutting-edge technology to address the unmet needs of patients suffering from conditions such as multiple sclerosis, Alzheimer's disease, and spinal muscular atrophy. The company is committed to advancing the understanding of the underlying biology of these diseases and is actively engaged in clinical trials to evaluate new treatment options, aiming to improve patient outcomes and enhance quality of life. With a global presence and a robust pipeline of therapies, Biogen is at the forefront of innovation in the biopharmaceutical industry.

Locations

Seoul, , Korea, Republic Of

Daegu, , Korea, Republic Of

Seoul, , Korea, Republic Of

Daejeon, , Korea, Republic Of

Seoul, , Korea, Republic Of

Daegu, , Korea, Republic Of

Gwangju, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Busan, , Korea, Republic Of

Yangsan, , Korea, Republic Of

Seoul, , Korea, Republic Of

Cheongju Si, , Korea, Republic Of

Daegu, , Korea, Republic Of

Daejeon, , Korea, Republic Of

Jeonju Si, , Korea, Republic Of

Changwon, , Korea, Republic Of

Seoul, Gangnam Gu, Korea, Republic Of

Changwon, , Korea, Republic Of

Cheongju Si, , Korea, Republic Of

Jeonju, , Korea, Republic Of

Yangsan, , Korea, Republic Of

Busan, , Korea, Republic Of

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Medical Director

Study Director

Biogen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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