A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrophy Previously Treated with Risdiplam - ASCEND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505639-11-00

Acronym

232SM303

Enrollment

Registered

2024-06-19

Start date

2022-09-14

Completion date

Unknown

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Muscular Atrophy

Brief summary

Change in Total Revised Upper Limb Module (RULM) Score [ Time Frame: Up to Day 855 ]

Detailed description

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 1695 ], Number of Participants With Change in Clinical Laboratory Parameters, Electrocardiogram (ECG), Vital Signs and Pulse Oximetry from Baseline [ Time Frame: Up to Day 1695 ]

Interventions

DRUGSPINRAZA 50 mg

DRUGSPINRAZA 28 mg

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change in Total Revised Upper Limb Module (RULM) Score [ Time Frame: Up to Day 855 ]	—

Secondary

Measure	Time frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 1695 ], Number of Participants With Change in Clinical Laboratory Parameters, Electrocardiogram (ECG), Vital Signs and Pulse Oximetry from Baseline [ Time Frame: Up to Day 1695 ]	—

Countries

Germany, Hungary, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026