A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)

Trial Profile

A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Sep 2017

At a glance

  • Drugs Omaveloxolone (Primary)
  • Indications Friedreich's ataxia
  • Focus Registrational; Therapeutic Use
  • Acronyms MOXIe
  • Sponsors Reata Pharmaceuticals
  • Most Recent Events

    • 25 Sep 2017 Planned End Date changed from 1 Aug 2021 to 1 Dec 2022.
    • 25 Sep 2017 Planned primary completion date changed from 1 Feb 2019 to 1 Jan 2020.
    • 14 Aug 2017 According to a Reata Pharmaceuticals media release, the FDA recommended that the company extend the treatment duration for Part 2 of the study and add a straightforward patient-reported or performance-based outcome endpoint to the study.
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