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Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis

Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04892134
Enrollment
500
Registered
2021-05-19
Start date
2019-10-03
Completion date
2025-10-31
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

biomarker, progression, MRI, cognition

Brief summary

By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained

Detailed description

The current study aims to comprehensively investigate the individual clinical, morphological and biochemical aspects of MS in order to elucidate underlying mechanisms leading to disease progression. This shall ultimately serve to identify imaging and biochemical markers, which may support clinical management of persons with MS (pwMS). The following markers will be assessed: demographics (age, sex), clinical (EDSS at baseline, disease duration); neuropsychological (SDMT (Symbol Digit Modalities Test) score); MRI (Magnetic Resonance Imaging) (lesion load, atrophy); Biochemical markers analyzed in cerebrospinal fluid (CSF), blood, DNA, RNA, peripheral blood mononuclear cells (PBMCs)

Interventions

OTHERblood sample

40-50 ml of blood is taken

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with suspected or proven multiple sclerosis * The participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria

Exclusion criteria

* Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic

Design outcomes

Primary

MeasureTime frameDescription
Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the diseasea maximum of 4 yearsEDSS score

Secondary

MeasureTime frameDescription
Prediction of clinical relapsesa maximum of 4 yearsPrediction of clinical relapses
Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteriaa maximum of 4 yearsConversion from CIS to MS defined by MRI and clinical criteria
Time of transition to progressive form of MSa maximum of 4 yearsTime of transition to progressive form of MS
Neuropsychological progression (decrease in SDMT performance)a maximum of 4 yearsNeuropsychological progression (decrease in SDMT performance)
Increase in morphological damage (lesion load, atrophy)a maximum of 4 yearsIncrease in morphological damage (lesion load, atrophy)

Countries

Austria

Contacts

Primary ContactChristian Enzinger, Prof.
chris.enzinger@medunigraz.at+43/316/ 385-82180
Backup ContactMichael Khalil, MD
michael.khalil@medunigraz.at+43/316/385-30313

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026