Status:
COMPLETED
Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection
Lead Sponsor:
Biogen
Conditions:
Muscular Atrophy, Spinal
Eligibility:
All Genders
Brief Summary
The primary objective of this study is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in China.The secondary objectives are to collect data on the efficacy and the ...
Eligibility Criteria
Inclusion
- Key
- Ability of the participant or his/her legally authorized representative (e.g., parent or legal guardian), as appropriate and applicable, to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
- The decision to newly prescribe nusinersen sodium injection according to the local marketing authorization, including documentation of 5q SMA diagnosis, has been made by the Investigator and agreed to by the participant (or legally authorized representative)
- Key
Exclusion
- Hypersensitivity to the active substance or any of the excipients of nusinersen sodium injection.
- Current or past administration of nusinersen sodium injection, in either a commercial or a clinical study setting.
- Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04419233
Start Date
November 18 2020
End Date
November 21 2023
Last Update
December 7 2023
Active Locations (9)
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1
Research Site
Xicheng, Beijing Municipality, China, 100045
2
Research Site
Fuzhou, Fujian, China, UNK
3
Research Site
Guangzhou, Guangdong, China, UNK
4
Research Site
Suzhou, Jiangsu, China, UNK