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Clinical Trials/IRCT201406018323N10
IRCT201406018323N10
Completed
Phase 4

The evaluation of the efficacy and safety of oral fingolimod in relapsing remitting multiple sclerosis

Vice-chancellor for research, Kermanshah University of Medical Sciences0 sites60 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
multiple sclerosis.
Sponsor
Vice-chancellor for research, Kermanshah University of Medical Sciences
Enrollment
60
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Vice-chancellor for research, Kermanshah University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • 1\.Patients with Relapsing\- Remitting Multiple Sclerosis (RRMS) based on McDonald's Criteria (2010\)
  • 2\.age between 18 to 45 years
  • 3\. EDSS between 0 to 5\.5
  • 4\. at least one relapse in previous year while receiving first line disease modifying therapy
  • 5\.at least 2 relapses in previous 2 years while receiving first line disease modifying therapy
  • 6\. no relapses in 30 days previous to fingolimod initiation
  • 7\. negative pregnancy tests in child bearing women
  • 8\. positive history of varicella zoster virus vaccination or positive anti varicella zoster antibody in serum
  • Exclusion criteria:
  • 1\. primary or secondary progressive MS

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

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