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

Biogen

Status: Enrolling

Conditions: Muscular Atrophy, Spinal

Treatments: Drug: Nusinersen Sodium Injection

Study type: Observational

Funder types: Industry

Identifiers

NCT04317794

232SM403

Details and patient eligibility

About

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.

Enrollment: 145 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

145 participants in 1 patient group

All Participants

Description:

Participants who were prescribed with nusinersen sodium injection in Korea according to local marketing authorization.

Treatment:

Drug: Nusinersen Sodium Injection