Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS

Danish Multiple Sclerosis Research Centre0 个研究点开始时间: 2009年5月15日最近更新: 2016年8月8日

研究概览

暂无简介。

•Age between 19 and 55 years inclusive. Multiple Sclerosis (MS) according to the revised McDonald criteria: either primary progressive MS or secondary progressive MS without relapses during the last one year. MS disease duration of at least two years from onset of disease. Progression of more than 1 point on the EDSS scale during the last 2 years. EDSS (Expanded Disability Status Score) of more than or equal to 4 and less than or equal to 6.5.
•MRI scan of the brain that fulfills the Barkhof criteria for MS.
•Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Pregnancy or period of breastfeeding; missing adequate contraceptive protection for female patients with childbearing potential. Acceptable methods of birth control in this study include: sexually inactive, surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, longacting injectable contraceptive or a double-barrier method (condom or diaphragm with spermicide).
•Treatment with steroids in the last 30 days
•Previous treatment with EPO
•Treatment with interferons, glatiramer acetate or IVIG in the 3 months prior to enrolment
•Treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment
•Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension (systolic > 180, diastolic > 110)
•History of any haematological disorder
•History of renal insufficiency
•Any medical psychiatric or other circumstances which impede or restrict the subjects participation in the study in the manner intended
•Contraindication for MRI (e.g. pace maker, aortic clip or any metal implant)

发起方

Danish Multiple Sclerosis Research Centre