Clinical Trial

ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (OAV101B) (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)

Not Yet Recruiting Phase 4
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Summary
The primary purpose is to address critical evidence in the treatment landscape for Spinal Muscular Atrophy (SMA), specifically focusing on the intrathecal formulation of onasemnogene abeparvovec-brve (ITVISMA®). U.S. Pragmatic Multicenter Study (STREAM).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-02-26; most recent amendment 2026-05-28.
Trial Details
NCT Number NCT07448610
Lead Sponsor Novartis Pharmaceuticals
Conditions Spinal Muscular Atrophy
Enrollment 36 participants
Start Date 2026-07-01
Primary Completion 2032-05-03 (estimated)
Study Completion 2032-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-29