Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)
NCT ID: NCT04317794
Last Updated: 2025-07-17
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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ACTIVE_NOT_RECRUITING
74 participants
OBSERVATIONAL
2019-07-02
2027-02-05
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 who were prescribed with nusinersen sodium injection in Korea according to 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
* Genetic documentation of 5q-linked SMA
Exclusion Criteria
* 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
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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Pusan Natioanl University Hospital
Busan, , South Korea
Samsung Changwon Hospital
Changwon, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea university Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Natioanl University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Other Identifiers
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232SM403
Identifier Type: -
Identifier Source: org_study_id
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