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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 Infantile-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 Infantile-onset Spinal Muscular Atrophy

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2022

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At a glance

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

    • Most Recent Events

    • 09 Nov 2022 Pooled 2-year risdiplam analysis from NCT02913482 & NCT02193074 assessing relative efficacy and safety of risdiplam versus nusinersen in Type 1 spinal muscular atrophy presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 10 Jun 2021 According to a Biogen media release, data predicting the potential efficacy of an investigational higher dose regimen of SPINRAZA using data from phase 2 CS3A and phase 3 ENDEAR study are being presented at the virtual Cure SMA Research & Clinical Care Meeting
    • 10 Jun 2021 An analysis of data from the Phase 2 CS3A and Phase 3 ENDEAR studies in children with infantile-onset SMA used pharmacokinetic (PK)/pharmacodynamic (PD) modelling to predict the potential efficacy of an investigational higher dose regimen of SPINRAZA, results published in the Biogen Media Release

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