Clinical trial NCT01371071: Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis
Official title: Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis, MS
Clinically Isolated Syndrome
Keywords: Clinically isolated syndrome (CIS)
Multiple sclerosis (MS)
Immunomodulatory therapy
Prognostic markers
MRI
OCT
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruted at neurological outpatient clinics and neurologcial clinics of the charité and neurologists' medical practices.

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.


Eligibility criteria: 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

Primary outcomes:
measure: time (in days) until relapse during the observation period of four years
timeFrame: 48 months
Secondary outcomes:
measure: MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI)
timeFrame: 48 months
measure: biomarkers: RNA, microRNA, DNA, proteins, enzymes, autoantibodies, antiviral antibodies, virus DNA, Vitamin D and lipids in serum, plasma, peripheral cells, urine, saliva and CSF
timeFrame: 48 months
measure: Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)
timeFrame: 48 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Neurology, Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite - Universitätsmedizin Berlin
name: Friedemann Paul, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Klemens Ruprecht, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Judith Bellmann-Strobl, Dr.
role: PRINCIPAL_INVESTIGATOR
References: