Fatigue in Multiple Sclerosis and Its Relationship to Inflammatory and Neurodegenerative Markers of the Disease

NCT07025122 | Enrolling By Invitation DMC

• 2 other identifiers: ID68/2024VEGA 01/0092/22
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fatigue in Multiple Sclerosis; Multiple Sclerosis; Neurofilaments Light Chains; GFAP; HLA DRB 1501; BCL6 (rs969625); OS9 (rs701006)

Keywords

fatigue, mitochondriopathy, neurofilaments, GFAP, genetics; intergenic variant near BCL6; intronic variant in OS9

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  5 years after the last reqruited patient

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• Clinical diagnosis of multiple sclerosis using McDonald2017 criteria Patients indicated to immunomodulatory treatment

You may not qualify if:

• Multimorbidities

Sponsors & Collaborators

• University Hospital, Martin: lead
• Comenius University: collaborator

Study Sites (1)

University Hospital in Martin, Comenius University

Martin, Slovakia, 03601, Slovakia

Location

Related Links

• Jessenius Faculty of Medicine in Martin, Comenius University Bratislava

Biospecimen

Retention: SAMPLES WITH DNA

HLA antigens

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Petra Hnilicová, PhD Ing

  Comenius University

  STUDY CHAIR

• Ema Kantorová, prof MD PhD

  UHMartin and Comenius University

  PRINCIPAL INVESTIGATOR

• Martin Kolísek, assoc.prof RNDr, Dr.rer.nat.

  Comenius University

  STUDY CHAIR

• Štefan Sivák, prof.MD, PhD

  UHMartin and Comenius University

  STUDY DIRECTOR

• Natália Huňarová, Mgr, doctorand

  Comenius University

  STUDY CHAIR

• Andrea Ižarik Verešpejová, Mgr, doctorand

  Comenius University

  STUDY CHAIR

• Daniel Čierny, associate prof, MD, PhD

  UHMartin and Comenius University

  STUDY CHAIR

• Vladimír Nosáľ, associate prof, MD, PhD

  UHMartin, Comenius University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: June 17, 2025
• Study Start: January 26, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: March 2025
• Access Criteria: E-mail communication is preferable access

Locations

SL (1)