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Study identifier: NCT06451757 Synced from ClinicalTrials.gov · July 29, 2026
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KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases

Condition: Mitochondrial Diseases · Maternally Inherited Diabetes and Deafness (MIDD) · Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS)  ·  Sponsor: Khondrion BV

PhasePhase 3
Planned participants220
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The KHENERFIN study aims to determine whether the study medicine, sonlicromanol, is able to reduce symptoms of fatigue and the impact of fatigue on daily life, and whether sonlicromanol is able to improve physical abilities of people like balance control and lower limb skeletal muscle strength in people with mitochondrial disease. In this study, the effects of sonlicromanol are compared against a placebo, a tablet identical in appearance and taste but without the active drug. Participants take either sonlicromanol or placebo twice daily for a treatment duration of 52 weeks. In addition to these primary objectives, the study evaluates the efficacy of sonlicromanol on secondary and exploratory outcomes, as well as its safety and tolerability after one year of treatment.

This description comes directly from the study's public registry record.

Talk to the study team

Jasper Levink, MSc.  ·  +31 24 7635000  ·  Khenerfin@khondrion.com

G. Ruiterkamp, MSc.  ·  +31 24 7635000  ·  Khenerfin@khondrion.com

Always discuss trial participation with your own doctor first.

Locations (10)

Massachusetts General HospitalBoston, Massachusetts, United StatesNot Yet Recruiting
Cleveland Clinic Neurological Institute Mellen CenterCleveland, Ohio, United StatesNot Yet Recruiting
The University of Texas Health Science Center at HoustonHouston, Texas, United StatesRecruiting
Rigshospitalet, University of CopenhagenKopenhagen, Region Sjælland, DenmarkNot Yet Recruiting
CHU de Bordeaux - Hôpital Pellegrin Service Gynecologie ObstetriqueBordeaux, Gironde, FranceNot Yet Recruiting
Groupe Hospitalier Pitie-Salpetriere - Charles-Foix Clinical Investigation Center Paris-EstParis, Paris, FranceNot Yet Recruiting
Klinikum der Universität München Friedrich-Baur-InstitutMünchen, GermanyRecruiting
Fondazione IRCCS Istituto Neurologico Carlo BestaMilan, ItalyRecruiting
Radboud University Medical CenterNijmegen, Gelderland, NetherlandsRecruiting
University College London Hospitals NHS Foundation Trust National Hospital for Neurology and NeurosurgeryLondon, Greater London, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT06451757