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Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis

NCT01371071 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2011-06-10

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, MS
  • Clinically Isolated Syndrome

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Friedemann Paul, Prof. · Charite - Universitätsmedizin Berlin

  • Klemens Ruprecht, Dr. · Charite University, Berlin, Germany

  • Judith Bellmann-Strobl, Dr. · Charite University, Berlin, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01371071 on ClinicalTrials.gov