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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)

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Jul 1, 2026 to Aug 27, 2026 · Secondary endpoints: details revised at 5 of 12 entries · 1 more Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2026 to Aug 27, 2026
    • Secondary endpoints: details revised at 5 of 12 entries
    • Eligibility criteria shortened, about 4 words
  2. Re-verified, no change to tracked fieldsv3
  3. Completion date: Apr 1, 2034 to Jun 30, 2032v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07448610
Lead Sponsor Novartis Pharmaceuticals
Conditions Spinal Muscular Atrophy
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov