Fatigue in Multiple Sclerosis and Its Relationship to Inflammatory and Neurodegenerative Markers of the Disease
Launched by UNIVERSITY HOSPITAL, MARTIN · Jun 9, 2025
Trial Information
Current as of September 11, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The MITOFATIGUE study in Slovakia is an observational study about fatigue in people with multiple sclerosis (MS). Researchers will look at several blood and genetic markers, plus tests of mitochondrial (cell energy) function, to see how these relate to disease activity and how fatigued a person feels. The main goal is to measure fatigue and see how it lines up with markers like neurofilament light chain (NfL), GFAP, and mitochondrial activity, along with standard MS checks (EDSS score and MRI). This “multimodal” approach aims to help predict how MS may progress and to improve how doctors manage treatment.
Eligible participants are adults 18 and older who have been newly diagnosed with MS and are about to start immune‑system–related treatment. The study plans to enroll about 100 people and will include two groups: (1) people tested before starting treatment and again about 12 months later, and (2) all newly diagnosed patients who meet the standard diagnostic criteria invited to participate, with yearly follow‑ups after treatment starts. Healthy volunteers are invited as controls for comparison. Exclusions include other significant health problems. Participants can expect up to 5 years of follow‑up with visits every six months, yearly MRIs, and yearly tests of fatigue, blood biomarkers, mitochondrial function, and genetic markers, all to better understand MS and guide future care. The study is ongoing and overseen by a data monitoring committee, with results anticipated through 2028.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Clinical diagnosis of multiple sclerosis using McDonald2017 criteria Patients indicated to immunomodulatory treatment
- Exclusion Criteria:
- • Multimorbidities
About University Hospital, Martin
University Hospital Martin is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to patient-centered care and cutting-edge medical practices, the hospital collaborates with a diverse array of researchers and healthcare professionals to explore new therapeutic approaches and improve patient outcomes. Its state-of-the-art facilities and multidisciplinary teams enable the rigorous evaluation of novel treatments, contributing to the global body of medical knowledge while enhancing the quality of care provided to the community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Martin, Slovakia
Patients applied
Trial Officials
Petra Hnilicová, PhD Ing
Study Chair
Comenius University
Ema Kantorová, prof MD PhD
Principal Investigator
UHMartin and Comenius University
Martin Kolísek, assoc.prof RNDr, Dr.rer.nat.
Study Chair
Comenius University
Štefan Sivák, prof.MD, PhD
Study Director
UHMartin and Comenius University
Natália Huňarová, Mgr, doctorand
Study Chair
Comenius University
Andrea Ižarik Verešpejová, Mgr, doctorand
Study Chair
Comenius University
Daniel Čierny, associate prof, MD, PhD
Study Chair
UHMartin and Comenius University
Vladimír Nosáľ, associate prof, MD, PhD
Study Chair
UHMartin, Comenius University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported