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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Apr 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

  • 24 Mar 2025 According to a Praxis Precision Medicines media release, data from this study will be presented in a Poster presentation (P5-012) on Saturday, April 5, 11:45 AM - 12:45 PM PT, at the American Academy of Neurology (AAN) 2025 Annual Meeting taking place from April 5 to 9, 2025 in San Diego, California.
  • 28 Feb 2025 According to a Praxis Precision Medicines media release, Given the advanced state of enrollment for both Study 1 and Study 2 in the Essential3 program, and in the context of the advice received by the IDMC, Praxis has decided to continue both studies to completion, with topline results expected in the third quarter of 2025. The decision about whether the data supports the submission of an NDA will be made after analyzing the final results for Study 1 and Study 2.
  • 28 Feb 2025 According to a Praxis Precision Medicines media release, Based on the predefined decision framework for Study 1, the IDMC has recommended that the study be stopped for futility, due to the results being unlikely to meet the primary efficacy endpoint under the parameters set by the statistical model. The committee also indicated that some underlying assumptions of the statistical model might have influenced this outcome and encouraged Praxis to explore alternative analysis methods.

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