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Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease

We're studying how KL1333 helps adults with primary mitochondrial disease.

Recruiting
18 years and older
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

The FALCON study is investigating a new medicine called KL1333 for people with Primary Mitochondrial Disease (PMD). PMD is a condition that affects the cells' powerhouses, leading to fatigue and muscle weakness. The study aims to see if KL1333 can help reduce fatigue and improve strength over 48 weeks. Participants will take KL1333 or a placebo pill (a pill that has no medicine) twice a day. The study will compare results to see if KL1333 is effective and safe. It lasts up to 65 weeks, starting with screening and ending with follow-ups.

  • Duration: Up to 65 weeks with 48 weeks of treatment.
  • Visits: Regular check-ups required during the study.
  • Randomization: Participants have a higher chance of getting KL1333 (3 out of 5) rather than placebo (2 out of 5).

Consider joining if you're 18 or older with a confirmed PMD diagnosis and can commit to the study duration. Ensure you meet the health criteria and are okay with potentially not knowing if you'll receive KL1333 or placebo. If you join, you must pause certain supplements and medications during the study.

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Study details
    Primary Mitochondrial Disease

NCT05650229

Abliva AB

25 April 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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