Clinical Trial

Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials

Study acronym: SPECTRUM
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-10
notable Enrollment reduced: 175 -> 20 participants 2026-07-10
notable Primary completion pushed: 2030-09-26 -> 2031-04-29 2026-07-10
minor Completion pushed: 2031-02-27 -> 2031-04-30 2026-07-10
Trial Details
NCT Number NCT05335876
Lead Sponsor Novartis Pharmaceuticals
Conditions Spinal Muscular Atrophy (SMA)
Enrollment 20 participants
Start Date 2022-12-19
Primary Completion 2031-04-29 (estimated)
Study Completion 2031-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-09