Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)
About the study
The primary objective is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in Korea. The secondary objective is to evaluate the effectiveness of nusinersen sodium injection in the postmarketing setting in Korea.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Currently receiving or about to initiate treatment with commercial Spinraza in the postmarketing setting
- Genetic documentation of 5q-linked SMA
EXCLUSION CRITERIA
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Muscular Atrophy, Spinal
Participants needed
145
Est. Completion Date
Jul 1, 2027
Treatment type
Observational
Sponsor
Biogen
ClinicalTrials.gov identifier
NCT04317794
Study number
232SM403
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