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A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis

Trial Profile

A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Nov 2019

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At a glance

  • Drugs Arimoclomol (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ORARIALS-01
  • Sponsors Orphazyme
  • Most Recent Events

    • 22 Jul 2019 According to a CytRx Corporation media release, A total of 213 patients have been randomized 2:1 to receive arimoclomol or placebo and up to an additional 18 individuals on stable treatment with edaravone may participate in the U.S. Patients completing the trial will be offered participation in an open-label extension trial. Orphazyme anticipates announcing top-line results from the Phase 3 trial in the first half of 2021.
    • 20 Jun 2019 Status changed from recruiting to active, no longer recruiting.
    • 02 May 2019 According to a CytRx corporation media release, regulatory submission of arimoclomol in amyotrophic-lateral-sclerosis is expected in H2 2021.
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