Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)
Launched by BIOGEN · Mar 20, 2020
Trial Information
Current as of June 26, 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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
Medical Director
Study Director
Biogen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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