2023-503420-19-00已完成3 期
A prospective, randomized, double-blind, placebo-controlled, two-stage, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity in children and adolescents with cerebral palsy
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Change in derived modified Ashworth Scale (MAS) score of plantar flexors from baseline at control visits at week 4 and week 6
研究概览
简要总结
To demonstrate efficacy by showing superiority of NT 201 compared intra-individually to placebo in children and adolescents with LL SP caused by CP at week 4 to week 6 after a single injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Open Label Extension Period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects ≥ 2 to ≤ 17 years of age
- •Bilateral, symmetrical pes equinus due to LL SP caused by CP in subjects with any Gross Motor Function Classification System (GMFCS) level
- •Identical MAS plantar flexor score of ≥ 2 for pes equinus clinical patterns in both legs at neutral ankle position and knee at maximum extension
- •Main eligibility criteria for Open-Label Extension Period (OLEX): MAS plantar flexor score of ≥ 1 in both pes equinus clinical patterns
- •Main eligibility criteria for Open-Label Extension Period (OLEX): Agreement of investigator, parent(s), and subject (if applicable) to continue treatment
排除标准
- •Pre-dominant forms of muscle hypertonia/hyperactivity other than LL SP (e.g., rigidity, dystonia, dyskinesia)
- •Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in any body region within the last four months before injection at baseline visit
- •Fixed contracture in at least one of both pes equinus
- •Significant involuntary movements or limitations that hinder MAS assessment or positioning
- •Clinically significant SP in LL clinical patterns other than pes equinus; or gait patterns drop foot, crouch gait, and equinus with jump knee
- •Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30°
结局指标
主要结局
Change in derived modified Ashworth Scale (MAS) score of plantar flexors from baseline at control visits at week 4 and week 6
Change in derived modified Ashworth Scale (MAS) score of plantar flexors from baseline at control visits at week 4 and week 6
次要结局
- GICS-PF score at control visits at week 4 and week 6 by investigator
- GAS T-score at control visits at week 4 and week 6
- Response in derived MAS score of plantar flexors at control visits at week 4 or week 6 with response defined as improvement of at least 1 point on the derived MAS score as compared to study baseline
研究者
Contact Point Clinical Trials
Scientific
Merz Pharmaceuticals GmbH
研究点 (4)
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