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A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Later-onset Spinal Muscular Atrophy

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Trial Profile

A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Later-onset Spinal Muscular Atrophy

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2021

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At a glance

  • Drugs Nusinersen (Primary)
  • Indications Spinal muscular atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms CHERISH
  • Sponsors Biogen; Ionis Pharmaceuticals

    • Most Recent Events

    • 22 Apr 2021 Results (n=75) assessing association between plasma phosphorylated neurofilament heavy chain (pNF-H) levels and clinical motor function endpoints in nusinersen-treated individuals with later-onset spinal muscular atrophy (SMA) in patients participated in the CHERISH/SHINE studies, presented at the 73rd Annual Meeting of the American Academy of Neurology.
    • 19 Apr 2021 According to a Biogen media release, data from this study is being presented at the Biogen Media Release.
    • 19 Apr 2021 Results published in the Biogen Media Release

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