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Primary Mitochondrial Disease clinical trials

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NCT ID: NCT05972954 Recruiting - Clinical trials for Primary Mitochondrial Disease

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

PMD-OPTION
Start date: May 22, 2023
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT05250375 Recruiting - Clinical trials for Primary Mitochondrial Disease

Mitochondrial Myopathy Rating Scale

Start date: March 24, 2017
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to develop and validate tools to measure disease course in patients with primary mitochondrial myopathy (PMM). The main aims of this study are: - Development, validation, and optimization of objective outcome measures for mitochondrial myopathy - Defining the natural history of mitochondrial myopathy Researchers will compare data from patients with primary mitochondrial myopathy to healthy controls. Data from healthy controls will also help define normative data for future studies. Participants will perform clinical exams of muscle strength and endurance and will complete surveys.