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OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION)

NCT05972954 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • Primary Mitochondrial Disease

Interventions

DRUG

OMT-28

once daily

Sponsors & Collaborators

  • Omeicos Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Robert Fischer, MD · Omeicos Therapeutics GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-22
Primary Completion
2025-05-14
Completion
2025-07-30

Countries

  • Germany
  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05972954 on ClinicalTrials.gov