Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis

Clinically Isolated Syndrome Clinical Trial

— CIS-COHORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01371071
• Other study ID #: EK1/2011
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2011
• Last updated: June 9, 2011
• Start date: January 2011
• Est. completion date: December 2017

Study information

• Verified date: June 2011
• Source: Charite University, Berlin, Germany
• Contact: Friedemann Paul, Prof.
• Phone: 0049 30 450
• Email: friedemann.paul[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Multiple Sclerosis, MS
• Sclerosis
• Syndrome

Locations

Country	Name	City	State
Germany	Department of Neurology, Charité - Universitätsmedizin Berlin	Berlin
Germany	NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time (in days) until relapse during the observation period of four years		48 months	No
Secondary	MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI)		48 months	No
Secondary	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	No
Secondary	Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)		48 months	No

External Links

•   Homepage of the Department of Neurology, Charité
•   Homepage of the NeuroCure Clinical Research Center