Fatigue in Multiple SclerosisMITOFATIGUENCT07025122
Fatigue in Multiple Sclerosis and Its Relationship to Inflammatory and Neurodegenerative Markers of the Disease
An observational study of Fatigue in Multiple Sclerosis and Multiple Sclerosis, run by University Hospital, Martin at 1 site in Slovakia.
Trial summary
The study is focused on several independent quantifiable biomarkers (sNfL, sGFAP, mitochondrial activity, genetics and fatigue tests) to obtain more detailed information about MS and its progression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue in Multiple Sclerosis, Multiple Sclerosis, Neurofilaments Light Chains
- How many people
- 100 participants
- Where
- 1 siteSlovakia
- Study dates
- 26 Jan 2024to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients newly diagnosed with multiple sclerosis will be invited to participate in observational prospective study before starting any immunomodulatory treatment. The tests will be repeated on yearly base. Results of studied biomarkers will be evaluate and compare with clinical tests results (EDSS, relapse rate and MRI outcome - NEDA-3).
Who may be able to join
- Clinical diagnosis of multiple sclerosis using McDonald2017 criteria Patients indicated to immunomodulatory treatment
Who cannot join
- Multimorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site
University Hospital in Martin, Comenius University
Martin, Slovakia, 03601
About this study
The study is focused on several independent quantifiable biomarkers (sNfL, sGFAP, mitochondrial activity, genetics and fatigue tests) to obtain more detailed information about MS and its progression. Based on the results, investigator will further attempt to predict the course of the disease and manage the therapy more effectively to prevent worsening of the patient's condition.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the CNS, leading to non-traumatic neurological impairment in young people. Disability progression in MS is commonly recognized as the disability worsening occurring in patients with progressive MS or in the absence of relapse activity in relapsing progressing MS. This process can begin early in the disease and is not always halted by current therapeutics. The ability to accurately select between active, active progressive and nonactive progressive patients is crucial.
The aim of the proposed study is to use a multimodal approach to achieve better diagnosis and more accurate prediction of disease progression in an individual patient. The diagnostic modalities will include the evaluation of fatigue questionnaires (FIS, ESS, HADS, RAND-36), biomarkers examination: serum neurofilament light chain (sNfL) and glial fibrillary acidic protein (sGFAP), and mitochondrial respiratory capacity.
The fatigue questionnaire battery is considered an advanced examination that is not commonly performed in MS patients. The Fatigue Impact Scale (FIS) is a tool used to assess the impact of fatigue on various aspects of a patient's life. This questionnaire measures the extent to which fatigue affects physical, cognitive, and psychosocial functioning and helps quantify the severity of fatigue. The Epworth Sleepiness Scale (ESS) is a simple questionnaire used to measure daytime sleepiness, helping to differentiate increased fatigue in patients from potential sleep disorders. Additionally, HADS and RAND-36 is included in the study to rule out potential associations of fatigue with other external influences.
NfL is known to be an excellent biomarker of focal inflammatory activity but lacks the ability to reflect the pathology that drives disease progression. Neurodegeneration and astrocytic activation can be quantified by glial fibrillary acidic protein (sGFAP). Previous research revealed, that higher levels of sGFAP correlated with subsequent progression, particularly in nonactive patients, whereas sNfL reflected acute disease activity in patients with MS at high risk of underlying progressive pathology.
Mitochondria, traditionally recognized as cellular 'powerhouses' due to their pivotal role in energy production, have emerged as multifunctional organelles at the intersection of bioenergetics, metabolic signalling, and immunity. Investigators propose mitochondria as the leading immune organelles, drawing parallels with the broader immune system in their functions of antigen presentation, immune regulation, and immune response. Investigators also consider mitochondria's ability to detect and release danger signals, regulate immune functions, and engage in intercellular crosstalk. Investigators plan to analyse mitochondrial function by means of high-resolution respirometry with the Oroboros O2k in all study participants.
The human leukocyte antigen (HLA) DRB1*1501, which has been consistently associated with MS nearly in all populations will be evaluated in all participants of the study. The HLA-DRB1*15:01 haplotype is of importance in the interaction between B and T cells in MS patients, while two autosomal genome-wide significant MS risk alleles significantly alter the distribution B-cell subsets. Investigators are planning to test an intergenic variant near BCL6 (rs969625), associated with high MS risk and decreased naive/memory ratios, and an intronic variant in OS9 (rs701006) corresponded to low MS risk.
The study is focused on several independent quantifiable parameters to obtain more detailed information about MS and its progression. Based on the results, investigators will further attempt to predict the course of the disease and manage the therapy more effectively to prevent worsening of the patient's condition.
- Conditions
- Fatigue in Multiple Sclerosis, Multiple Sclerosis, Neurofilaments Light Chains, GFAP, HLA DRB 1501, BCL6 (rs969625)
- Keywords
- fatigue, mitochondriopathy, neurofilaments, GFAP, genetics, intergenic variant near BCL6, intronic variant in OS9
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| newly diagnosed multiple sclerosis patients | Newly diagnosed multiple sclerosis patients will be tested before initiation of any immunomodulatory treatment. Tests will be repeated 12 months later. | |
| All newly diagnosed patients fulfilling McDonal 2017 criteria will be invited to participate. | All newly diagnosed patients fulfilling McDonal 2017 criteria will be invited to participate. Tests will be performed before starting any immunomodulatory treatment. The tests will be performed yearly after initiation of their treatment and evaluated accordingly. Effectivity of the treatment will be evaluated traditionally using NEDA-3 criteria on a yearly base. Control group will consist of healthy volunteers. They will be tested ones after entering the study. The tests will include Fatigue questionnaires, sNfL, sGFAP, mitochondrial activity and genetics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of fatigue and comparision with sNfL, sGFAP, and mitochondrial activity
Baseline:
- Tests of serum biomarkers (NfL,GFAP), mitochondrial activity using Oroboros, and questionnaires (FIS, ESS, HANDS, RAND)
- Genetic tests: the HLA-DRB1*15:01 haplotype, an intergenic variant near BCL6 (rs969625) and an intronic variant in OS9 (rs701006)
- Characteristics of patient´s disease - neurological disability using EDSS, relapses, MRI activity will be recorded
Follow- up:
Patients will be evaluated every 6 months, involving standardized neurological examination. Burden of the disease will be evaluated prospectively.
Number of relapses will be evaluated yearly and annualized relapse rate will be calculated. EDSS score will be evaluated every 6 months. MRI activity will be tested yearly. Levels of NfL" and GFAP, mitochondrial activity, and questionnaires will also be tested yearly.
Effectiveness of the disease modifying treatment will be evaluated continuously up to 5 years since the onset.
Measured: The patients will be tested yearly. All markers will be evaluated prospectively. The Time Frame is from date of randomization up to 5 years
Secondary outcomes (1)
Correlation of genetic characteristics, biomarkers, fatigue tests, and mitochondrial status with the disease burden.
Calculation of NEDA-3 in each clinical year. Correlation of clinical characteristics with NfL, GFAP, mitochondrial functioning, and genetic determinants to evaluate disease burden
Time Frame Jan/2024 1-12/2025 1-12/2026 Reqruitement of MS patients, collection o biomarkers and results of fatigue tests. EDSS and MRI recorded yearly. Disease modiying treatment according to slovak rules www.nczis.gov
1-12/2027 1-12/2028 Statistical evaluation, publication of results Statistical evaluation, publication o results
Measured: 5 years after the last reqruited patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start26 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue in Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Collaborators
- Comenius University
- Responsible party
- Sponsor
- Investigators
- Petra Hnilicová, PhD Ing, Study chair, Comenius UniversityEma Kantorová, prof MD PhD, Principal investigator, UHMartin and Comenius UniversityMartin Kolísek, assoc.prof RNDr, Dr.rer.nat., Study chair, Comenius UniversityŠtefan Sivák, prof.MD, PhD, Study director, UHMartin and Comenius UniversityNatália Huňarová, Mgr, doctorand, Study chair, Comenius UniversityAndrea Ižarik Verešpejová, Mgr, doctorand, Study chair, Comenius UniversityDaniel Čierny, associate prof, MD, PhD, Study chair, UHMartin and Comenius UniversityVladimír Nosáľ, associate prof, MD, PhD, Study chair, UHMartin, Comenius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025122
- Sponsor's protocol ID
- ID68/2024
- Other IDs
- VEGA 01/0092/22
- Acronym
- MITOFATIGUE
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * to inform scientific community about the plant * to find cooperators