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An Open-label Phase 2 Extension Study to Evaluate the Long Term Safety and Efficacy of Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With GNE Myopathy or Hereditary Inclusion Body Myopathy

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Trial Profile

An Open-label Phase 2 Extension Study to Evaluate the Long Term Safety and Efficacy of Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With GNE Myopathy or Hereditary Inclusion Body Myopathy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Mar 2018

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At a glance

  • Drugs Aceneuramic acid (Primary) ; Aceneuramic acid (Primary)
  • Indications Nonaka distal myopathy
  • Focus Adverse reactions
  • Sponsors Ultragenyx Pharmaceutical

    • Most Recent Events

    • 14 Sep 2017 Status changed from active, no longer recruiting to completed.
    • 08 Apr 2016 Planned primary completion date changed from 1 Jun 2016 to 1 Feb 2017.
    • 10 Nov 2014 Two-year results published in Ultragenyx Pharmaceutical media release.

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