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Search / Trial NCT07025122

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

Fatigue, Mitochondriopathy, Neurofilaments, Gfap, Genetics Intergenic Variant Near Bcl6 Intronic Variant In Os9

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.

Locations

Martin, Slovakia

Patients applied

0 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