NCT00313976撤回3 期
A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Bayer
- 主要终点
- Magnetic Resonance Imaging (MRI): T2-lesions
研究概览
简要总结
The purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS for no less than one year and no longer than ten years
- •Disease in the secondary progressive (SP) phase
- •At least one relapse the last 3 years
- •Treatment with an interferon for at least 6 months and with Betaferon for at least 3 months
排除标准
- •Serious or acute heart disease
- •Severe depression
- •Serious or acute liver, kidney or bone marrow dysfunction
- •Epilepsy not adequately treated
- •Pregnancy or lactation
- •Alcohol or drug abuse
研究组 & 干预措施
Arm 1
Experimental
干预措施: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) (Drug)
Arm 2
Experimental
干预措施: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Magnetic Resonance Imaging (MRI): T2-lesions
时间窗: At week 104
次要结局
- Neutralizing antibodies(At week 104)
- Adverse events(At week 104)
- Hospitalizations(At week 104)
- Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)(At week 104)
- Relapses(At week 104)
- Further Magnetic Resonance Imaging (MRI) parameters(At week 104)
研究者
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