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Phase 2b Randomized, Double-blind, Placebo-controlled Crossover Study Evaluating the Efficacy and Safety of Zagociguat in Participants With MELAS (PRIZM)

Trial Profile

Phase 2b Randomized, Double-blind, Placebo-controlled Crossover Study Evaluating the Efficacy and Safety of Zagociguat in Participants With MELAS (PRIZM)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Jun 2025

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At a glance

  • Drugs Zagociguat (Primary)
  • Indications Lactic acidosis; Mitochondrial encephalomyopathies; Stroke
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PRIZM
  • Sponsors Tisento Therapeutics

Most Recent Events

  • 14 May 2025 According to a Tisento Therapeutics media release, company will share key learnings related to the design of our Phase 2b PRIZM study in MELAS at the primary mitochondrial diseases public workshop, hosted by the Reagan-Udall Foundation for the FDA.
  • 14 May 2025 According to a Tisento Therapeutics media release, Planned number of patients changed from 36 to 44.
  • 27 Jan 2025 According to a Tisento Therapeutics media release, first patient has been dosed in its global Phase 2b PRIZM study and is now enrolling in North America, Europe, and Australia.

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