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Clinical trial

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group, Pivotal Trial to Assess the Efficacy and Safety of Sonlicromanol in Adult Subjects With a Genetically Confirmed Mitochondrial DNA tRNALeu(UUR) m.3243A>G Variant

NCT06451757 is registered in ClinicalTrials.gov with Khondrion BV as lead sponsor.

NCT NCT06451757
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group, Pivotal Trial to Assess the Efficacy and Safety of Sonlicromanol in Adult Subjects With a Genetically Confirmed Mitochondrial DNA tRNALeu(UUR) m.3243A>G Variant
Lead sponsor
Khondrion BV
Phase
Phase 3
Overall status
Recruiting
Start date
April 14, 2026
Completion date
September 30, 2029
Enrollment
220 (estimated)
Sites
10

Conditions

As the registry lists them; a condition with its own page is linked.

maternally inherited diabetes and deafness (midd), mitochondrial diseases, mitochondrial dna trnaleu(uur) m.3243a<g mutation, mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (melas)