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A Phase III Open-Label, Single Group Extension Study of the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

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Trial Profile

A Phase III Open-Label, Single Group Extension Study of the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2023

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At a glance

  • Drugs Idebenone (Primary)
  • Indications Friedreich's ataxia
  • Focus Therapeutic Use
  • Acronyms IONIA-E
  • Sponsors Santhera Pharmaceuticals

Most Recent Events

  • 20 Nov 2014 New trial record
  • 11 Jul 2011 The primary endpoint has been changed from hematology, nature and frequency of AEs, blood and urine chemistry, physical/neurological examination and vital signs, electrocardiograms to change in ICARS, according to ClinicalTrials.gov (NCT00697073).
  • 20 Aug 2010 The study was changed from recruiting to completed.

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