NCT00146159终止3 期
A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 336 人开始时间: 2005年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 336
- 主要终点
- 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)
研究概览
简要总结
The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Secondary progressive MS in an active stage
- •EDSS between 3 and 6
排除标准
- •Benign or primary progressive MS
- •Patients with cardiac risk factors
- •Patients who have already received mitoxantrone
研究组 & 干预措施
1
Experimental
1st group: 12 mg Mitoxantrone/m²
干预措施: Mitoxantrone (Drug)
2
Experimental
2nd group: 9mg Mitoxantrone/m²
干预措施: Mitoxantrone (Drug)
3
Experimental
3rd group: 5mg Mitoxantrone/m²
干预措施: Mitoxantrone (Drug)
结局指标
主要结局
3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)
时间窗: 3 years
deterioration, change of ambulation index, time to first relapse requiring corticoid treatment
时间窗: 3 years
次要结局
- derivations of EDSS and relapses; MRI (baseline, 2 years)(3 years)
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