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.
Investigators
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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