Multiple Sclerosis, MSCIS-COHORTNCT01371071
Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis
An observational study of Multiple Sclerosis, MS and Clinically Isolated Syndrome, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
A majority of patients with multiple sclerosis initially presents with a single demyelinating event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically isolated syndrome (CIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, MS, Clinically Isolated Syndrome
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2011to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruted at neurological outpatient clinics and neurologcial clinics of the charité and neurologists' medical practices.
Who may be able to join
- age > 18 years
- signed informed consent
- clinically isolated syndrome within the last 6 months
- diagnosis of multiple sclerosis within the last two years
Who cannot join
- eye disease that could interfere with OCT (e.g. glaucoma, diabetic retinopathy)
- secondary progressive multiple sclerosis
- pregnancy
- contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
- alcohol or drug abuse
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Department of Neurology, Charité - Universitätsmedizin Berlin
Berlin
Klemens Ruprecht, Dr., 0049 30 450 ext. 560 374, klemens.ruprecht@charite.de
- Recruiting
NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Berlin
Friedemann Paul, Prof., 0049 30 450 ext. 539040, friedemann.paul@charite.de
Seija Lehnardt, Prof.
About this study
Official title: Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT)
A majority of patients with multiple sclerosis initially presents with a single demyelinating event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically isolated syndrome (CIS). Not all patients with CIS get a relapse and develop multiple sclerosis but in those patients who do, irreversible damage of the central nervous system, e.g. axonal damage, is already detectable in that early stage of disease. Early initiation of immunomodulatory therapy is crucial for patients with clinically isolated syndrome who are at high risk for the development of multiple sclerosis. Vice versa identification of low risk patients could help to avoid an unnecessary therapy. In this prospective observational study we want to follow up patients with CIS and early multiple sclerosis over a period of four years and obtain clinical, laboratory and MRI - data in order to identify risk factors for relapses, prognostic factors and therapy response markers.
- Keywords
- Clinically isolated syndrome (CIS), Multiple sclerosis (MS), Immunomodulatory therapy, Prognostic markers, MRI, OCT
- Medical subject headings
- Multiple Sclerosis
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 |
|---|---|---|
| CIS or early relapsing-remitting MS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
time (in days) until relapse during the observation period of four years
Measured: 48 months
Secondary outcomes (3)
MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI)
Measured: 48 months
biomarkers: RNA, microRNA, DNA, proteins, enzymes, autoantibodies, antiviral antibodies, virus DNA, Vitamin D and lipids in serum, plasma, peripheral cells, urine, saliva and CSF
Measured: 48 months
Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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 Sclerosis, MSStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Friedemann Paul, Prof., Principal investigator, Charite - Universitätsmedizin BerlinKlemens Ruprecht, Dr., Principal investigator, Charite University, Berlin, GermanyJudith Bellmann-Strobl, Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371071
- Sponsor's protocol ID
- EK1/2011
- Acronym
- CIS-COHORT
- Status last verified
- Jun 2011
- First submitted
- 8 Jun 2011
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gottwald NS, Asseyer S, Chien C, Brasanac J, Nauman AT, Rust R, Schmitz-Hubsch T, Strobl JB, Ruprecht K, Paul F, Regitz-Zagrosek V, Gold SM, Sperber PS. Impact of sex on clinical outcome in early Multiple Sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105749. doi: 10.1016/j.msard.2024.105749. Epub 2024 Jun 29.
PubMed 38959589
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT)
- ClinicalTrials.gov ID
- NCT01371071
- Acronym / sponsor ID
- CIS-COHORT / EK1/2011
- Keywords
- Clinically isolated syndrome (CIS), Multiple sclerosis (MS), Immunomodulatory therapy, Prognostic markers, MRI, OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Jun 2011 (estimated)
- 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.
A majority of patients with multiple sclerosis initially presents with a single demyelinating event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically isolated syndrome (CIS). Not all patients with CIS get a relapse and develop multiple sclerosis but in those patients who do, irreversible damage of the central nervous system, e.g. axonal damage, is already detectable in that early stage of disease. Early initiation of immunomodulatory therapy is crucial for patients with clinically isolated syndrome who are at high risk for the development of multiple sclerosis. Vice versa identification of low risk patients could help to avoid an unnecessary therapy. In this prospective observational study we want to follow up patients with CIS and early multiple sclerosis over a period of four years and obtain clinical, laboratory and MRI - data in order to identify risk factors for relapses, prognostic factors and therapy response markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIS or early relapsing-remitting MS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruted at neurological outpatient clinics and neurologcial clinics of the charité and neurologists' medical practices.
Key inclusion criteria (4 listed)
- age > 18 years
- signed informed consent
- clinically isolated syndrome within the last 6 months
- diagnosis of multiple sclerosis within the last two years
Key exclusion criteria (5 listed)
- eye disease that could interfere with OCT (e.g. glaucoma, diabetic retinopathy)
- secondary progressive multiple sclerosis
- pregnancy
- contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
- alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time (in days) until relapse during the observation period of four years
Time frame: 48 months
3 secondary outcomes
MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI)
Time frame: 48 months
biomarkers: RNA, microRNA, DNA, proteins, enzymes, autoantibodies, antiviral antibodies, virus DNA, Vitamin D and lipids in serum, plasma, peripheral cells, urine, saliva and CSF
Time frame: 48 months
Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Derived from this study: PubMed 38959589Gottwald NS, Asseyer S, Chien C, Brasanac J, Nauman AT, Rust R, Schmitz-Hubsch T, Strobl JB, Ruprecht K, Paul F, Regitz-Zagrosek V, Gold SM, Sperber PS. Impact of sex on clinical outcome in early Multiple Sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105749. doi: 10.1016/j.msard.2024.105749. Epub 2024 Jun 29.
- Homepage of the NeuroCure Clinical Research CenterLink provided by the sponsor.
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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.
Friedemann Paul, Prof. principal investigator
Charite - Universitätsmedizin Berlin
Klemens Ruprecht, Dr. principal investigator
Charite University, Berlin, Germany
Judith Bellmann-Strobl, Dr. principal investigator
Charite University, Berlin, Germany
2 sites 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, MS and Clinically Isolated Syndrome, run by Charite University, Berlin, Germany at 2 sites in Germany.
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 4 inclusion and 5 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 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Friedemann Paul, Prof. (0049 30 450 ext. 539040, friedemann.paul@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time (in days) until relapse during the observation period of four years (time frame: 48 months). 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 NCT01371071, 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 10 Jun 2011.