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

Study acronym: KH176-301
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2028 → Sep 2029
See other at-risk trials from Khondrion BV

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2028 to Sep 2029 Show 4 more changesShow less
    • Eligibility criteria shortened, about 19 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
    • Site details revised at 3 of 10 sites
  2. Start date changed from estimate of Feb 2026 to Apr 14, 2026
    • Eligibility criteria revised
    • Site details revised at 4 of 10 sites
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 28, 2025 to Feb 2026
    • Primary and study completion dates: Jul 2, 2028 to Sep 2028
    • Site details revised at 10 of 10 sites
    v5
  4. Primary and study completion dates: Jan 2, 2028 to Jul 2, 2028v4 Show 5 more changesShow less
    • Enrollment target: 150 to 220
    • Study sites: 0 to 10
    • Eligibility criteria shortened, about 1,078 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 24 words
  5. Start date: Aug 2, 2025 to Nov 28, 2025v3
  6. Primary and study completion dates: Jul 2, 2027 to Jan 2, 2028
    • Start date: Jan 2, 2025 to Aug 2, 2025
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Khondrion BV
1 trial monitored
See 1 trial at risk
Diabetes
5,087 trials monitored
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Stroke
3,531 trials monitored
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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.
Trial Details
NCT Number NCT06451757
Lead Sponsor Khondrion BV
Conditions
(from sponsor)		 Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS), Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
Related terms MELAS Syndrome, Mitochondrial Diseases, Noninsulin-dependent diabetes mellitus with deafness
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov