Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection
NCT ID: NCT04419233
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2020-11-18
2023-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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All Participants
Participants with 5q SMA and who were prescribed with nusinersen sodium injection in China according to the local marketing authorization.
Nusinersen Sodium Injection
Administered as specified in the treatment arm.
Interventions
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Nusinersen Sodium Injection
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Xicheng, Beijing Municipality, China
Research Site
Fuzhou, Fujian, China
Research Site
Guangzhou, Guangdong, China
Research Site
Suzhou, Jiangsu, China
Research Site
Changchun, Jilin, China
Research Site
Minhang, Shanghai Municipality, China
Research Site
Chengdu, Sichuan, China
Research Site
Beijing, Xicheng, China
Research Site
Hangzhou, Zhejiang, China
Countries
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References
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Jiang Y, Wang Y, Xiong H, Li W, Luo R, Chen W, Yin F, Lu J, Liang J, Chen WJ, Lu X, Wang H, Tang J, Monine M, Makepeace C, Jin X, Foster R, Chin R, Berger Z. A Post-Marketing Surveillance Study of Nusinersen for Spinal Muscular Atrophy in Routine Medical Practice in China: Interim Results. Adv Ther. 2024 Jul;41(7):2743-2756. doi: 10.1007/s12325-024-02852-7. Epub 2024 May 9.
Other Identifiers
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232SM402
Identifier Type: -
Identifier Source: org_study_id