Overview

KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases

Status:
NOT_YET_RECRUITING

Trial end date:
2028-01-02

Target enrollment:

Participant gender:

Summary

The KHENERFIN study is investigating whether the study medicine, sonlicromanol, is able to improve symptoms of fatigue and the impact of fatigue on daily life, and whether sonlicromanol is able improve physical abilities of people living with mitochondrial disease, such as balance control and lower limb skeletal muscle strength. For this study, the effects of sonlicromanol are compared with those from a placebo (study medication that looks like the actual study medicine but contains no active medicine). The study medicine (or placebo) is a powder that is dissolved in water and must be taken twice daily during the treatment period of 52 weeks. Additionally, the study evaluates the efficacy of sonlicromanol on selected secondary and exploratory outcome measures, as well as the safety and tolerability of sonlicromanol after 52 weeks of treatment with sonlicromanol.

Phase:

PHASE3

Details

Lead Sponsor:

Khondrion BV

Treatments:

6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid