Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892134
• Other study ID #: MarkMS
• Status: Recruiting
• Start date: October 3, 2019
• Est. completion date: October 31, 2025

Study information

• Verified date: October 2023
• Source: Medical University of Graz
• Contact: Christian Enzinger, Prof.
• Phone: +43/316/ 385-82180
• Email: chris.enzinger[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• blood sample
40-50 ml of blood is taken

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease	EDSS score	a maximum of 4 years
Secondary	Prediction of clinical relapses	Prediction of clinical relapses	a maximum of 4 years
Secondary	Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteria	Conversion from CIS to MS defined by MRI and clinical criteria	a maximum of 4 years
Secondary	Time of transition to progressive form of MS	Time of transition to progressive form of MS	a maximum of 4 years
Secondary	Neuropsychological progression (decrease in SDMT performance)	Neuropsychological progression (decrease in SDMT performance)	a maximum of 4 years
Secondary	Increase in morphological damage (lesion load, atrophy)	Increase in morphological damage (lesion load, atrophy)	a maximum of 4 years