NCT00221611已完成2 期
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Spasticity of patients after 4 years
研究概览
简要总结
Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales
详细描述
Evaluation of the effect of intrathecal administration of Baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CP patients with therapy-resistent spasticity
- •Patients with sufficient body weight in relation to the volume
- •Oral medication has failed: insufficient effect or too many side-effects
- •The patient and family understand the objectives of the treatment and accept those objectives
- •Informed Consent
排除标准
- •Contra-indications for surgery (e.g. infection)
- •Hypersensitivity to oral Baclofen
结局指标
主要结局
Spasticity of patients after 4 years
次要结局
未报告次要终点
研究者
研究点 (2)
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