NCT01450488已完成2 期
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis
AB Science0 个研究点目标入组 35 人开始时间: 2005年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- change in MSFC
研究概览
简要总结
The purpose of this study is to evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or secondary progressive multiple sclerosis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion.
- •Patients with EDSS score in the range of 2 to 6.5, inclusive
- •EDSS progression ≥ 1 point within 2 years before inclusion
排除标准
- •Disease other than MS responsible for clinical signs and/or MRI lesions
- •Secondary progressive MS with relapse in the 2 years before inclusion
- •Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation
- •Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation.
- •Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
研究组 & 干预措施
masitinib 3 mg/kg/day
Experimental
干预措施: masitinib (Drug)
masitinib 6 mg/kg/day
Experimental
干预措施: masitinib (Drug)
结局指标
主要结局
change in MSFC
时间窗: 12 months
average change in multiple sclerosis functional composite (MSFC) score relative to baseline, with clinical response defined as a \> 100% improvement (increase) from baseline
次要结局
- MFSC subcategories(12 months)
- MSFC subcategories(12 months)
- Expanded Disability Status Scale (EDSS)(12 months)
研究者
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