IRCT201406018323N10CompletedPhase 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 enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 45 years (—)
- Sex
- All
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
- •2. history of chronic systemic disease other than MS (lung, liver, kidney,...disease)
- •3. history of or active malignancy
- •4. presence of macular edema at baseline
- •5. acute or chronic active bacterial, viral or fungal infection
- •6. treatment with IV corticosteroids during 30 days previous to fingolimod initiation
- •7. history of treatment with cyclophosphamide or mitoxantrone at any time
- •8. history of treatment with immunoglobulins or monclonal antibodys in previous 6 months
- •9. history of treatment with methotroxate or azathioprine in previous 6 months
- •10. pregnancy or lactation
- •11. inocculation of live attenuated vaccines in previous 2 months
- •12. history of unstable angina, MI, TIA or CVA in previous 6 months
- •13. history of hospitalization due to decompensated heart failure in previous 6 months
- •14. Canada heart association class 3 or 4 heart failure
- •15. history or presence of second degree mobitz type AV block, third degree AV block or sick sinus syndrome, except having functional cardiac pace maker
- •16. QT interval more than 500 millisecond on baseline EKG
- •17. treatment with antiarythmic drugs class 1a or class 3
- •18. AST or ALT two folds normal upper limit
- •19. ALP 1.5 folds normal upper limit
- •20. direct or total Billi more than normal upper limit
- •21. creatinin more than 1.7 mg/dl
- •22. WBC less than 3500/ mm3
- •23. lymphocyte count less than 800/ mm3
- •24. presence of uveitis
Exclusion Criteria
- Not provided
Investigators
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