Overview
Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2026-05-30
2026-05-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566). The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Biogen
Criteria
Key Inclusion Criteria:- Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the
study protocol.
Key Exclusion Criteria:
- Treatment with another investigational therapy or enrollment in another interventional
clinical study.
- Treatment with an approved therapy for SMA that is inconsistent with protocol
requirements for allowed or disallowed concomitant therapies
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.