Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis

• Conditions: Multiple Sclerosis, MS; Clinically Isolated Syndrome

• Registration Number: NCT01371071
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-06
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-09
• Last Update Submitted: 2011-06-09
• Study First Posted: 2011-06-10
• Last Update Posted: 2011-06-10
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time (in days) until relapse during the observation period of four years	48 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Department of Neurology, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany