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An Open-Label, Dose Escalation Study to Assess the Safety, Tolerability and Dose-Range Finding of Multiple Doses of ISIS 396443 Delivered Intrathecally to Patients With Spinal Muscular Atrophy

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Trial Profile

An Open-Label, Dose Escalation Study to Assess the Safety, Tolerability and Dose-Range Finding of Multiple Doses of ISIS 396443 Delivered Intrathecally to Patients With Spinal Muscular Atrophy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Nusinersen (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions
  • Acronyms SMNRx-CS2
  • Sponsors Biogen; Ionis Pharmaceuticals; Isis Pharmaceuticals

    • Most Recent Events

    • 22 Jun 2021 Results from NCT01703988; NCT02052791 and NCT02594124, assessing long term improved/maintained motor function in nusinersen treated children with later onset Spinal-muscular-atrophy, presented at the 7th Congress of the European Academy of Neurology
    • 10 Jun 2021 According to Biogen media release, results of post hoc analysis of CS2-CS12 and SHINE extension study are being presented at the virtual Cure SMA Research & Clinical Care Meeting.
    • 10 Jun 2021 Results of post hoc analysis of CS2-CS12 and SHINE extension study published in the Media Release

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