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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: 20 Jul 2026

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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

  • 16 Jul 2026 Planned End Date changed from 1 Dec 2026 to 1 Jul 2028.
  • 07 May 2026 According to a Praxis Precision Medicines media release, data from this trial was presented at the American Academy of Neurology (AAN) Annual Meeting.
  • 14 Apr 2026 According to a Praxis Precision Medicines media release, based on the data from the trial, the U.S. FDA has accepted for review its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor (ET) in adults. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2027 and is not planning to hold an advisory committee meeting.

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