EUCTR2004-002855-15-GB进行中（未招募）不适用
A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In addition to having met the inclusion criteria described in the original protocol, to participate in the extension study, patients must:
- •- have completed the original protocol, Study No. CTCH346A2211
- •- be capable of satisfying the requirements of the extension study protocol and must sign the informed consent after the nature of the extension study protocol has been fully explained.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria as described in the original protocol will remain applicable into the extension protocol.
研究者
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