EUCTR2012-005496-14-Outside-EU/EEA进行中（未招募）1 期
Prospective, multicenter, randomized, double-blind, parallel-group, dose-response study of three doses Xeomin® (incobotulinumtoxinA, NT 201) for the treatment of upper limb spasticity alone or combined upper and lower limb spasticity in children and adolescents (age 2 - 17 years) with cerebral palsy. - XARA – IncobotulinumtoXinA in aRm treatment in Cerebral PAlsy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 344
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
- •- Female or male subject of 2 to 17 years of age (inclusive).
- •- Uni- or bilateral cerebral palsy CP with clinical need for injections with NT 201 for the treatment of upper limb spasticity at least unilaterally.
- •- Ashworth Scale (AS) score in the main clinical target patterns in this study: a.Flexed elbow: AS=2 in elbow flexors (at least unilaterally). And/or b.Flexed Wrist: AS=2 in wrist flexors (at least unilaterally).
- •- Clinical need according to the judgment of the investigator in one out of five treatment combinations.
- •- AS score must be =2 for each target pattern chosen for injection at the Baseline Injection Visit V2.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 344
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pre-treated (non-naïve) subjects must not have received BoNT treatment within the last 14 weeks prior to the Screening Visit (V1) in any indication.
研究者
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