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Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis

Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01371071
Acronym
CIS-COHORT
Enrollment
200
Registered
2011-06-10
Start date
2011-01-31
Completion date
2017-12-31
Last updated
2011-06-10

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

Conditions

Clinically Isolated Syndrome, Multiple Sclerosis, MS

Keywords

Clinically isolated syndrome (CIS), Multiple sclerosis (MS), Immunomodulatory therapy, Prognostic markers, MRI, OCT

Brief 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). 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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age \> 18 years * signed informed consent * clinically isolated syndrome within the last 6 months * diagnosis of multiple sclerosis within the last two years

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
time (in days) until relapse during the observation period of four years48 months

Secondary

MeasureTime frame
MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI)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 CSF48 months
Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)48 months

Countries

Germany

Contacts

Primary ContactFriedemann Paul, Prof.
friedemann.paul@charite.de0049 30 450
Backup ContactKlemens Ruprecht, Dr.
klemens.ruprecht@charite.de0049 30 450

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026