Status:
ACTIVE_NOT_RECRUITING
Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)
Lead Sponsor:
Biogen
Conditions:
Muscular Atrophy, Spinal
Eligibility:
All Genders
Brief Summary
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 inje...
Eligibility Criteria
Inclusion
- Key
- Currently receiving or about to initiate treatment with commercial Spinraza in the postmarketing setting
- Genetic documentation of 5q-linked SMA
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
July 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 5 2027
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04317794
Start Date
July 2 2019
End Date
February 5 2027
Last Update
July 17 2025
Active Locations (16)
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1
Pusan Natioanl University Hospital
Busan, South Korea
2
Samsung Changwon Hospital
Changwon, South Korea
3
Chungbuk National University Hospital
Cheongju-si, South Korea
4
Kyungpook National University Hospital
Daegu, South Korea