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Phase 3, Decentralized, Randomized, Double-Blind, Placebo Controlled, Parallel Design, Randomized Withdrawal, and Long-term Safety Study to Evaluate the Efficacy and Safety of Ulixacaltamide (PRAX-944) in Adults With Essential Tremor

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Trial Profile

Phase 3, Decentralized, Randomized, Double-Blind, Placebo Controlled, Parallel Design, Randomized Withdrawal, and Long-term Safety Study to Evaluate the Efficacy and Safety of Ulixacaltamide (PRAX-944) in Adults With Essential Tremor

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

Latest Information Update: 16 Dec 2025

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At a glance

  • Drugs Ulixacaltamide (Primary)
  • Indications Essential tremor
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Essential3
  • Sponsors Praxis Precision Medicines

Most Recent Events

  • 04 Dec 2025 According to a Praxis Precision Medicines media release, the company announced the successful completion of its pre-NDA (New Drug Application) meeting with the FDA, including receipt of written feedback and an in-person meeting. The company has gained alignment from the agency on the content of the NDA and expects to complete its NDA submission in early 2026.
  • 16 Oct 2025 According to Praxis Precision Medicines media release, Praxis has submitted a pre-NDA meeting request to the FDA with plans to submit the NDA by early 2026, upon agreement with the agency.
  • 16 Oct 2025 Results presented in the Praxis Precision Medicines media release.

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