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

NCT04317794 · tracked via the Priya Life Science South Korea tracker

Sponsor

Biogen

Phase

Observational

Started

2019-07-02

Last updated

2026-07-27

Condition(s) studied

Muscular Atrophy, Spinal

Investigational drug(s) / intervention(s)

Nusinersen Sodium Injection →

Nusinersen Sodium Injection: Administered as specified in the treatment arm.

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to End of Treatment (2 Years)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.

Trial sites (16)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04317794 on ClinicalTrials.gov ↗ ← All trials in South Korea