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IRCT201112267419N4 IRCT 2012-09-07 Osvah Pharmaceutical Company Randomized, open labeled, multicenter study evaluating safety Fingolide® in patients with Relapsing- Remitting Multiple Sclerosis Randomized, open labeled, multicenter study evaluating safety Fingolide® in patients with Relapsing- Remitting Multiple Sclerosis 2012-08-21 anticipated 309 Complete https://irct.ir/trial/7881 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 4 Multiple Sclerosis. fingolimod capsule, chemical formulation FTY -720 , (0.5 mg/ day, oral , every day) for 12 months ,made in Osvah Pharmaceutical Company in Islamic Republic Of Iran, generic name Cap. Fingolide.
public Dr. Naghmeh Hadidi
5th floor - Number 112 - Western Hafezi street - Farahzadi Avenue - Shahrake gharb
Tehran Iran (Islamic Republic of) - +98 21 2213 1066 hadidi@gmail.com Osvah Pharmaceutical Company scientific Dr. Mohammad Ali Sahraian
Sina Hospital, before Hasan abad Square , Imam Khomeini Street.
Tehran Iran (Islamic Republic of) - +98 21 6634 8571 msahrai@sina.tums.ac.ir Sina Hospital Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 65 years Both G35 Disseminated Multiple Sclerosis Treatment - Drugs fingolimod capsule, chemical formulation FTY -720 , (0.5 mg/ day, oral , every day) for 12 months ,made in Osvah Pharmaceutical Company in Islamic Republic Of Iran, generic name Cap. Fingolide Relapse Rate. Timepoint: Before intervention and every month after intervention. Method of measurement: Physical examination done by neurologist and Expanded Disability Status Scale (EDSS). 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 ). Vice chancellor for research ,Tehran University of Medical Sciences Osvah Pharmaceutical Company Vice chancellor for research ,Tehran University of Medical Sciences Approved 2013-02-19 Tehran University of Medical Sciences Ethics Committee Vice chancellor for research ,Tehran University of Medical Sciences, Qods Street , Keshavarz Boulevard . Tehran Iran (Islamic Republic of)