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

Phase 4

• Conditions: multiple sclerosis.; Disseminated Multiple Sclerosis

• Registration Number: IRCT201406018323N10
• Lead Sponsor: Vice-chancellor for research, Kermanshah University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expanded disability score scale,EDSS. Timepoint: before intervention and every 3 months after intervention. Method of measurement: EDSS qustionair.

Secondary Outcome Measures

Name	Time	Method
Annual relapse rate. Timepoint: before intervention and monthly after intervention. Method of measurement: physical examination by neurologist and EDSS questionair.;Disability progression. Timepoint: before intervention and monthly after intervention. Method of measurement: one point increment in EDSS that remains for 3 months, without new relapse at the time of evaluation.;Drug side effects. Timepoint: before intervention and monthly after intervention. Method of measurement: patient reported complications and designed drug side effect questionair.