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A phase 3 12-week parallel clinical trial of ulixacaltamide (PRAX-944) for essential tremor

Trial Profile

A phase 3 12-week parallel clinical trial of ulixacaltamide (PRAX-944) for essential tremor

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 03 Jun 2024

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At a glance

  • Drugs Ulixacaltamide (Primary)
  • Indications Essential tremor
  • Focus Registrational; Therapeutic Use
  • Acronyms Essential3
  • Most Recent Events

    • 18 Apr 2024 Trial design presented at the 76th Annual Meeting of the American Academy of Neurology 2024.
    • 08 Jan 2024 According to a Praxis Precision Medicines media release, safety database for a NDA by ICH guidelines requiring 300 patients with six-months of exposure and 100 patients with one-year of exposure.
    • 08 Jan 2024 According to a Praxis Precision Medicines media release, enrollment in Essential3 remains on track, with plans to complete in the first half of 2024 and topline results expected in the second half of 2024, supporting a planned New Drug Application (NDA) submission in 2025.

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