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
试验速览
- 阶段
- 2 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group.
研究概览
简要总结
In a double-blind, placebo-controlled, parallel group trial, recombinant human erythropoietin (rhEPO) (48000 IU) treatment or placebo will be administered weekly i.v. for 24 weeks: weekly for 12 weeks and bi-weekly for 12 weeks. Methylprednisolone (MP) 1 g i.v. will be administered before the first and second EPO/placebo administration. The 24-week treatment period will be followed by a 24-week observation period.
详细描述
Patients with primary progressive MS or secondary progressive MS without relapses during the last 1 year will be suitable for the trial. In all 56 patients will be enrolled into the study.
The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 19 and 60 years
- •primary progressive MS or secondary progressive MS without relapses during the last one year
- •duration of the disease of at least 2 years Clinical disability progression should have been observed in the 2 years prior to screening as per clinical judgment of the investigator. In addition, progression must be documented by an increase in the EDSS score of at least 0.5 points at any time during the 2 years prior to Screening; or progression of 1 point in the pyramidal, cerebellar, brain stem , visual or sensory functional system during the last 2 years. Should documented EDSS scores not be available, a written summary of the clinical evidence of disability progression in the previous 2 years must be submitted (for example walking distance or hand function).
- •EDSS (Expanded Disability Status Scale) 4.0-6.5
- •MRI fulfilling the Barkhof criteria for MS
- •written informed consent
排除标准
- •pregnancy or period of breastfeeding or missing adequate contraceptive protection
- •treatment with steroids in the last 30 days
- •treatment with interferons, glatiramer acetate or IVIG in the last1 month 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 contrast enhanced MRI (e.g. pace maker, aortic clip or any metal implant)
研究组 & 干预措施
Erythropoietin
Erythropoietin treated patients contra placebo.
干预措施: Erythropoietin (Drug)
结局指标
主要结局
The primary outcome measure is the change from baseline to 24 weeks in a composite of maximum gait distance, 9-hole peg test, TRAIL making B comparing the placebo-treatment group with the EPO-treatment group.
时间窗: 48 weeks
次要结局
- Comparisons between the placebo-and the EPO-group regarding:difference in maximum gait distance between baseline and week 24.(48 weeks)
- Comparisons between the placebo-and the EPO-group regarding:difference in 9-hole peg test(48 weeks)
- Comparisons between the placebo-and the EPO-group regarding:difference in TRAIL making B(48 weeks)