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A Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Patients With Infantile-Onset Spinal Muscular Atrophy

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Trial Profile

A Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Patients With Infantile-Onset Spinal Muscular Atrophy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Jul 2022

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At a glance

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

Most Recent Events

  • 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
  • 16 Aug 2019 Results assessing integrated safety analysis evaluated end of study data from seven completed clinical trials (NCT01494701, NCT01703988, NCT01839656, NCT02193074, NCT02292537, NCT01780246, NCT02052791) that enrolled infants and children with symptomatic SMA who were treated with intrathecal nusinersen or underwent sham procedurespublished in the CNS Drugs

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