EUCTR2012-005054-30-EE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 lower limb spasticity in children and adolescents (age 2 - 17 years) with cerebral palsy - TIM - Treatment with IncobotulinumtoxinA in Movement
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
- 300
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
- •1. Female or male subject of 2 to 17 years of age (inclusive).
- •2. Uni- or bilateral cerebral palsy with clinical need for uni- or bilateral LL injections with BoNT for the treatment of spasticity.
- •3. Ashworth Scale [AS] score =2 in plantar flexors (at least unilaterally).
- •4. Clinical need for a total dose of 16 U/kg BW NT 201 (maximum of 400 U) for the treatment of LL spasticity according to the clinical judgment of the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •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
- •1. Fixed contracture defined as severe restriction of the range of joint movement on passive stretch or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s).
- •2. Surgery on pes equinus on side(s) intended to be treated with BoNT injections in this study within 12 months prior to Screening Visit (V1), in the screening period or planned for the time of participation in this study.
- •3. Hip flexion requiring BoNT injection.
- •4. Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30.
研究者
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