An open-label, uncontrolled, single-arm study of NT 201 in patients with spasticity in children.

Teijin Pharma Limited0 个研究点目标入组 44 人开始时间: 2025年2月28日最近更新: 2025年4月15日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Teijin Pharma Limited
入组人数: 44
主要终点: Modified Ashworth Scale(MAS) score in wrist flexors

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 2age old over 至 15age old not（—）
性别: All

入选标准

•(1)Patients aged 2 or more and less than 15 years at the time of obtaining informed consent
•(2)Patients who have been diagnosed with upper limb spasticity, lower limb spasticity, or upper and lower limb spasticity and who meet either or both of the following criteria:
•Patients who require administration of NT 201 to one or both upper limbs
•Patients who require administration of NT 201 to one or both lower limbs
•(3)Patients who meet the criteria for severity of spasticity at the time of pre-registration examination
•(4)If patients have previously undergone botulinum toxin treatment, 14 weeks or more have passed since their last botulinum toxin treatment before the pre-registration examination

排除标准

•(1)Patients with fixed contractures in the joints (wrists, elbows, knees, ankles, etc.) where NT 201 will be injected
•(2)Patients who have not seen any therapeutic effect from previous botulinum toxin treatments
•(3)Patients with an unhealed fracture at the injection site

结局指标

主要结局

Modified Ashworth Scale(MAS) score in wrist flexors

时间窗: 4 weeks after the first injection

Change from baseline in the Modified Ashworth Scale(MAS) score in wrist flexors

Modified Ashworth Scale(MAS) score in planter flexors

时间窗: 4 weeks after the first injection

Change from baseline in the Modified Ashworth Scale(MAS) score in planter flexors

次要结局

未报告次要终点

研究者

发起方

Teijin Pharma Limited

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