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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Charite University, Berlin, Germany
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01371071
First received: June 8, 2011
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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.


Condition
Multiple Sclerosis, MS
Clinically Isolated Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • time (in days) until relapse during the observation period of four years [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • biomarkers: RNA, microRNA, DNA, proteins, enzymes, autoantibodies, antiviral antibodies, virus DNA, Vitamin D and lipids in serum, plasma, peripheral cells, urine, saliva and CSF [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV) [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples (serum and plasma, with DNA), urine, saliva, CSF (if routine lumbar puncture was performed, no additional lumbar punctures for the study)


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
CIS or early relapsing-remitting MS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371071

Contacts
Contact: Friedemann Paul, Prof. 0049 30 450 ext 539040 friedemann.paul@charite.de
Contact: Klemens Ruprecht, Dr. 0049 30 450 ext 560374 klemens.ruprecht@charite.de

Locations
Germany
Department of Neurology, Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Klemens Ruprecht, Dr.    0049 30 450 ext 560 374    klemens.ruprecht@charite.de   
NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Friedemann Paul, Prof.    0049 30 450 ext 539040    friedemann.paul@charite.de   
Sub-Investigator: Seija Lehnardt, Prof.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Friedemann Paul, Prof. Charite - Universitätsmedizin Berlin
Principal Investigator: Klemens Ruprecht, Dr. Charite University, Berlin, Germany
Principal Investigator: Judith Bellmann-Strobl, Dr. Charite University, Berlin, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Friedemann Paul, MD; Klemens Ruprecht, MD; Judith Bellmann-Strobl, MD, Charité - Universiätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT01371071     History of Changes
Other Study ID Numbers: EK1/2011
Study First Received: June 8, 2011
Last Updated: June 9, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Clinically isolated syndrome (CIS)
Multiple sclerosis (MS)
Immunomodulatory therapy
Prognostic markers
MRI
OCT

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Syndrome
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Disease
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014