← Back to all trials
Active Not Recruiting
NCT04317794
Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)
Conditions: Muscular Atrophy, Spinal
Sex: All
Healthy volunteers: No
Enrollment: 74
Sponsor: Biogen
Location: Pusan Natioanl University Hospital Busan
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 injection in the postmarketing setting in Korea.
Eligibility Criteria
Key Inclusion Criteria:
* Currently receiving or about to initiate treatment with commercial Spinraza in the postmarketing setting
* Genetic documentation of 5q-linked SMA
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.
Source: ClinicalTrials.gov (NCT04317794). StuddyBuddy aggregates publicly available trial information.
