For Healthcare Professionals

Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Currently receiving or about to initiate treatment with commercial Spinraza in the postmarketing setting
  2. Genetic documentation of 5q-linked SMA Key

EXCLUSION CRITERIA

  1. Hypersensitivity to the active substance or any of the excipients of Spinraza
  2. 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
  3. Inability to comply with study requirements NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 866-633-4636Email iconEmail Study Center

Study’s details


Contition

Muscular Atrophy, Spinal

Age

0+

Participants needed

145

Est. Completion Date

Jul 2027

Treatment type

Observational


Sponsor

Biogen

ClinicalTrials.gov identifier

NCT04317794

Study number

232SM403

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