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An Open-label Study to Assess the Safety and Tolerability of a Single Intrathecal Dose of ISIS 396443 in Patients With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1

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Trial Profile

An Open-label Study to Assess the Safety and Tolerability of a Single Intrathecal Dose of ISIS 396443 in Patients With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Feb 2021

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At a glance

  • Drugs Nusinersen (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Ionis Pharmaceuticals; Isis 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
  • 14 Jul 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
  • 17 Sep 2013 Planned End Date changed from 1 Dec 2013 to 1 Feb 2014 as reported by ClinicalTrials.gov.

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