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An Open-label Study to Assess the Safety and Tolerability of ISIS 396443 in Patients With Spinal Muscular Atrophy Who Previously Participated in 396443-CS2 or 396443-CS10

Trial Profile

An Open-label Study to Assess the Safety and Tolerability of ISIS 396443 in Patients With Spinal Muscular Atrophy Who Previously Participated in 396443-CS2 or 396443-CS10

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 May 2020

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At a glance

  • Drugs Nusinersen (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions
  • Sponsors Biogen; Ionis Pharmaceuticals
  • Most Recent Events

    • 18 May 2020 Results published in the Biogen Media Release.
    • 01 May 2020 Results (n=5) of longer-term outcomes from patients initiated in CS2 trial (teenagers:14-15years), received Nusinersen in CS12 extension trial and transitioned to SHINE trial (adults) were presented at the 72nd Annual Meeting of the American Academy of Neurology
    • 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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