OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION)
Status:
Recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn about the treatment effects of the
investigational new drug OMT-28 in patients with Primary Mitochondrial Disease.
The main question[s] it aims to answer are:
- Is OMT-28 safe and well tolerated in this patient population?
- Does OMT-28 reduce Growth Differentiation Factor 15 (GDF-15) and other relevant blood
markers of mitochondrial dysfunction and inflammation?
- Does OMT-28 improve symptoms of the disease, e.g. fatigue or exercise intolerance?
Participants will be asked to participate in 6 study visits at an experienced clinical
center, including physical examinations and exercise tests, and take the study medication
regularly once per day according to the protocol.
Researchers will compare for every participant the results after 3 months and 6 months of
treatment with a preceding 3 month period of standard care treatment to investigate the
effects of OMT-28 on clinical parameters and a number of blood parameters.