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An Open-label, Escalating Dose Study to Assess the Safety, Tolerability and Dose-range Finding of a Single Intrathecal Dose of ISIS 396443 in Patients With Spinal Muscular Atrophy.

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An Open-label, Escalating Dose Study to Assess the Safety, Tolerability and Dose-range Finding of a Single Intrathecal Dose of ISIS 396443 in Patients With Spinal Muscular Atrophy.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Nusinersen (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors 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
    • 20 Mar 2013 Status changed from active, no longer recruiting to completed, based on results reported in an Isis Pharmaceuticals media release.
    • 14 Mar 2013 Phase I data was presented at the 2013 American Academy of Neurology Annual Meeting (AAN), according to an Isis Pharmaceuticals media release.

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