The Comparison of clinical and side effects of Cinnaferon with Betaferon in patients with Relapsing- Remitting Multiple Sclerosis

Cinnagen Pharmaceutical Company0 个研究点目标入组 76 人开始时间: 待定最近更新: 2018年2月22日

试验速览

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•1. Patients with Relapsing- Remitting Multiple Sclerosis based on McDonald's Criteria 2.age between 18-50 years old 3. Expanded Disability Status Scale (EDSS) 0- 5.5 4. Negative pregnancy test at baseline 5. Patients without Relapse in one last month 6. Signing consent form.
•-Exclusion criteria:
•1. Being pregnant during trial or intention to get pregnant in start of trial 2.Psychiatric disease or major depression 3.The history of suicide4. Allergy or hypersensitivity reaction to injected medication in the start of trial 5. Treatment with Intravenous immunoglobulin (IVIG) within six months prior to trial 6. The history of plasma exchange within 6 months prior to trial 7.Using cytotoxic medication within six months prior to trial 8. The history of using beta interferon within three months prior to trial 9.Impaired Liver Function Tests (more than 2times normal range) 10.Leukopenia (less than half of the normal range) 11. Other types of multiple sclerosis except relapsing- remitting type 12. Association with other autoimmune diseases 13. The history of malignancy 14 .The history of chronic liver disease except Gilbert's syndrome 15. The history of renal dysfunction with creatinine (Cr) more than 1.1mg/dl 16. Patients with the history of fear from Magnetic resonance Imaging (MRI)or Claustrophobia 17 .The history of sensitivity to Gadolinium (Gd) 18. Patient participation in another clinical trial at the same time 19. Breastfeeding .

发起方

Cinnagen Pharmaceutical Company