Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinerse

Phase 1

• Conditions: Muscular Atrophy, Spinal; MedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-004708-32-NL
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-06
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

- Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the study protocol.

NOTE: Other protocol defined Inclusion criteria may apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Treatment with another investigational therapy or enrollment in another interventional clinical study after the Day 302 visit in study 232SM203 (NCT04089566).
- Treatment with Zolgensma (all participants) after the Day 302 visit of study 232SM203 (NCT04089566).
- Treatment with an approved therapy for SMA (other than Zolgensma) that is inconsistent with protocol requirements for allowed or disallowed concomitant therapies.

NOTE: Other protocol defined Exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified