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A Phase IIb double-blind, randomised, placebo-controlled, multi-centre, confirmative three-way cross-over study on cognitive function with two doses of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation

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Trial Profile

A Phase IIb double-blind, randomised, placebo-controlled, multi-centre, confirmative three-way cross-over study on cognitive function with two doses of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Sonlicromanol (Primary)
  • Indications Mitochondrial disorders
  • Focus Therapeutic Use
  • Acronyms KHENERGYZE
  • Sponsors Khondrion

Most Recent Events

  • 06 Mar 2025 Results of phase 2b program consisting of a randomized controlled (RCT) study (dose-selection) followed by a 52-week open-label extension study (EXT, long-term tolerability, safety and efficacy of sonlicromanol), published in the Brain.
  • 08 Nov 2024 According to a Khondrion media release, the company announced the publication of results from its integrated Phase 2b clinical development program of sonlicromanol in the peer-reviewed scientific journal, Brain.
  • 22 Nov 2022 According to a Khondrion media release, the primary endpoint (Changes from baseline (measured at pre-dose Day 1) to end of treatment (Day 28 of each treatment period)) has not been met.

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