CTIS2023-503420-19-00招募中1 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 - M602011072
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
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°
研究者
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