Multiple Sclerosis. Disseminated Multiple Sclerosis
Conditions
Interventions
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.
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
Sponsors
Osvah Pharmaceutical Company
Vice chancellor for research ,Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 ). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Naghmeh Hadidi
Osvah Pharmaceutical Company
Outcome results
None listed