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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: 16 Aug 2019

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At a glance

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

    • 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
    • 24 Apr 2019 Long-term results assessing Nusinersen in later-onset spinal muscular atrophy in ISIS-396443-CS2 and ISIS-396443-CS12 studies, published in the Neurology
    • 22 Mar 2017 Status changed from active, no longer recruiting to completed.
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