Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis (CIS-COHORT)

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis, MS; Clinically Isolated Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Department of Neurology, Charité - Universitätsmedizin Berlin
    • Contact: Klemens Ruprecht, Dr.; Phone Number: 560 374 0049 30 450; Email: klemens.ruprecht@charite.de
  • Berlin, Germany
    • Recruiting
    • NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
    • Contact: Friedemann Paul, Prof.; Phone Number: 539040 0049 30 450; Email: friedemann.paul@charite.de
    • Sub-Investigator: Seija Lehnardt, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CIS or early relapsing-remitting MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time (in days) until relapse during the observation period of four years	48 months

Secondary Outcome Measures

Outcome Measure	Time 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 CSF	48 months
Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)	48 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Friedemann Paul, Prof., Charité - Universitätsmedizin Berlin; Principal Investigator: Klemens Ruprecht, Dr., Charite University, Berlin, Germany; Principal Investigator: Judith Bellmann-Strobl, Dr., Charite University, Berlin, Germany

Publications and helpful links

Helpful Links

• Homepage of the NeuroCure Clinical Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Estimate): June 10, 2011
• Last Update Submitted That Met QC Criteria: June 9, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: MRI; Clinically isolated syndrome (CIS); Multiple sclerosis (MS); Immunomodulatory therapy; Prognostic markers; OCT
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease; Multiple Sclerosis; Sclerosis; Syndrome
• Other Study ID Numbers: EK1/2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No