EUCTR2010-020886-26-ES进行中（未招募）不适用
Prospective, open-label, non-randomized, single-arm, multi-center dose titration study to investigate the safety and efficacy of NT 201 in subjects deemed to require total body doses of 800 U of NT 201 during the course of the study for the treatment of upper and lower limb spasticity of the same body side due to cerebral causes - TOWER
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •-Age from 18-80 yrs
- •-Upper and lower limb spasticity of the same body side due to cerebral causes
- •-Time since event leading to spasticity in the target body side greater than 12 weeks
- •-Need for 800 units Botulinum toxin type A
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •-Body weight below 50kg
- •-Fixed contractures of the target joint
- •-Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
- •-Infection at the injection site
研究者
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