Multiple SclerosisNCT04892134
Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Medical University of Graz at 1 site in Austria.
Trial summary
By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- blood sample
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 3 Oct 2019to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria with suspected or proven multiple sclerosis
Who may be able to join
- 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
Who cannot join
- Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8010
Christian Enzinger, Prof., +43/316/ 385-82180, chris.enzinger@medunigraz.at
Michael Khalil, MD, +43/316/385-30313, michael.khalil@medunigraz.at
About this study
Official title: Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS
By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained
Read the 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)
- Conditions
- Multiple Sclerosis
- Being tested
- blood sample
- Keywords
- biomarker, progression, MRI, cognition
- Medical subject headings
- Multiple Sclerosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
40-50 ml of blood is taken
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease
EDSS score
Measured: a maximum of 4 years
Secondary outcomes (5)
Prediction of clinical relapses
Prediction of clinical relapses
Measured: a maximum of 4 years
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
Measured: a maximum of 4 years
Time of transition to progressive form of MS
Time of transition to progressive form of MS
Measured: a maximum of 4 years
Neuropsychological progression (decrease in SDMT performance)
Neuropsychological progression (decrease in SDMT performance)
Measured: a maximum of 4 years
Increase in morphological damage (lesion load, atrophy)
Increase in morphological damage (lesion load, atrophy)
Measured: a maximum of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start3 Oct 2019
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Enzinger, Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892134
- Sponsor's protocol ID
- MarkMS
- Status last verified
- Oct 2023
- First submitted
- 4 May 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hechenberger S, Broeders TAA, Bet MDA, Helmlinger B, Tinauer C, Ropele S, Heschl B, Wurth S, Damulina A, Khalil M, Schoonheim MM, Enzinger C, Pinter D. Time-Varying Brain Functional Reconfiguration Patterns Associated With Fatigue in Multiple Sclerosis. Hum Brain Mapp. 2026 Mar;47(4):e70480. doi: 10.1002/hbm.70480.
PubMed 41797387
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS
- ClinicalTrials.gov ID
- NCT04892134
- Acronym / sponsor ID
- MarkMS
- Conditions
- Multiple Sclerosis
- Keywords
- biomarker, progression, MRI, cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria with suspected or proven multiple sclerosis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample40-50 ml of blood is taken | Other | – |
Primary outcome
Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease
Time frame: a maximum of 4 years
EDSS score
5 secondary outcomes
Prediction of clinical relapses
Time frame: a maximum of 4 years
Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteria
Time frame: a maximum of 4 years
Time of transition to progressive form of MS
Time frame: a maximum of 4 years
Neuropsychological progression (decrease in SDMT performance)
Time frame: a maximum of 4 years
Increase in morphological damage (lesion load, atrophy)
Time frame: a maximum of 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 41797387Hechenberger S, Broeders TAA, Bet MDA, Helmlinger B, Tinauer C, Ropele S, Heschl B, Wurth S, Damulina A, Khalil M, Schoonheim MM, Enzinger C, Pinter D. Time-Varying Brain Functional Reconfiguration Patterns Associated With Fatigue in Multiple Sclerosis. Hum Brain Mapp. 2026 Mar;47(4):e70480. doi: 10.1002/hbm.70480.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Enzinger, Prof principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Enzinger, Prof. (+43/316/ 385-82180, chris.enzinger@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease (time frame: a maximum of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.