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A Phase 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec

Trial Profile

A Phase 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec

Status: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 07 Feb 2025

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At a glance

  • Drugs Nusinersen (Primary)
  • Indications Spinal muscular atrophy
  • Focus Therapeutic Use
  • Acronyms RESPOND
  • Sponsors Biogen

Most Recent Events

  • 06 Mar 2024 The company announced interim 6-month biomarker data from the initial 29 participants and also the new data show that plasma neurofilament light chain (NfL) levels, an objective biomarker of axonal injury and neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA. These data will be presented at the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 3to6, 2024). according to a Biogen media release.
  • 06 Mar 2024 Interim results published in the Media Release
  • 15 Sep 2023 Planned End Date changed from 4 Sep 2024 to 7 Oct 2025.

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