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Open Label Extension Study of AMX0035 in Patients With ALS

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Trial Profile

Open Label Extension Study of AMX0035 in Patients With ALS

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Jun 2023

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At a glance

  • Drugs Sodium phenylbutyrate/ursodoxicoltaurine (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions
  • Acronyms CENTAUR-OLE
  • Sponsors Amylyx Pharmaceuticals

    • Most Recent Events

    • 27 Apr 2023 Results of a post-hoc analysis assessing potential effect of placebo-to-active crossover on intent-to-treat overall survival results from the CENTAUR and its OLE trial; was performed utilizing an external, propensity score-matched, PB&TURSO-naive cohort from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database as a historical control comparator presented at the 75th Annual Meeting of the American Academy of Neurology 2023
    • 01 Aug 2022 Results of a survival analyses of data from CENTAUR and open label extension study published in the Muscle and Nerve
    • 05 May 2022 Results presented in an Amylyx Pharmaceuticals media release.
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