Randomized, open labeled, multicenter study evaluating safety Fingolide® in patients with Relapsing- Remitting Multiple Sclerosis

Phase 4

• Conditions: Multiple Sclerosis.; Disseminated Multiple Sclerosis

• Registration Number: IRCT201112267419N4
• Lead Sponsor: Osvah Pharmaceutical Company

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: 309

Inclusion Criteria

Inclusion Criteria:
1.Patients with Relapsing- Remitting Multiple Sclerosis (MS) based on McDonald's Criteria (2010)
2. Age between 18-50 years old
3.Expanded Disability Status Scale (EDSS) 0- 5.5
4. Negative pregnancy test at baseline
5.Signing consent form
6. History of Chicken pox, VZV vaccination or positive antibody.
7. At least one documented relapse during one year prior to study while on first line disease modifying therapies.
8. No relapse during the last 30 days.

Exclusion Criteria :
1.Secondry or primary progressive MS
2.History of a chronic disease other than MS
3. History or presence of malignancy
4. Macular edema at onset
5. Active bacterial, fungal or viral infection
6. Treatment with corticosteorids (IV) during the past 30 days
7. Patients who have been previously treated with cyclophosphamide and mitoxantrone
8.Patients who have been treated with immunoglubulins or monoclonal antibodies during the past six months
9. Patients who have been treated with azothioprine or methtroxate during the past six months
10. Patients who have been treated with beta- Interferon or GA during the past 3 months
11.Medically Unstable patient according to site physician
12. Patient with history of syncope
13. History of cardiac arrest, heart failure, recurrent symptomatic bradycardia or ischemic heart disease
14. Abnormal Electro Cardio Gram (ECG) (Block, QT interval more than 440 milliseconds on screening ECG
15. Hypertension not controlled by prescribed medications
16.Patients with severe respiratory disease, Active pulmonary disease, Tuberculosis except successful treatment or prophylactic treatment after positive purified protein derivative (PPD)
17. Lost to follow up more than 3 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse Rate. Timepoint: Before intervention and every month after intervention. Method of measurement: Physical examination done by neurologist and Expanded Disability Status Scale (EDSS).

Secondary Outcome Measures

Name	Time	Method
Expanded Disability Status Scale. Timepoint: Before intervention and every month after intervention. Method of measurement: Physical examination done by neurologist based on revised Mc-Donald (2010).;Number and size of plaques and their enhancement. Timepoint: Before intervention and every six months after intervention. Method of measurement: Magnetic resonance Imaging ( MRI ).