JPRN-jRCT2080222976已完成3 期
Prospective, double-blind, placebo-controlled, randomized, multi-center study with an open-label lead-in tolerability period and an open-label extension period to investigate the efficacy and safety of two different doses of NT 201 in the treatment of post-stroke spasticity of the upper limb.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 111
研究概览
简要总结
The study confirmed efficacy of NT 201 for upper limb spasticity. Both high (400 U) and low (250 U) doses of NT 201 significantly improved the poststroke spasticity of upper limb as measured using AUC of changes in MAS score after a single injection over a period of 12 weeks. The study also confirmed the favorable safety and tolerability profile of NT 201 400 U in spasticity patients. No new or unexpected safety concerns were identified.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Female or male subjects from 20 to 80 (inclusive) years of age (less than 65 years during lead-in tolerability period).
- •-Body weight at least 40 kg.
- •-Unilateral upper-limb spasticity of wrist and fingers caused by a stroke at least 6 months before respective screening visit.
- •-Botulinum toxin-naïve or pretreated subjects with post-stroke spasticity of the upper limb. For pretreated subjects the last Botulinum toxin treatment must have been at least 16 weeks before the respective screening visit.
- •-Wrist flexor muscle tone is ≥ 3 and finger flexor muscle tone of at least 2 on the Modified Asworth Scale (MAS).
- •-At least one functional disability domain with a rating of at least 2 on the Disability Assessment Scale (DAS).
排除标准
- •-Fixed contracture or other muscle hypertonia in the affected joint(s) intended to be treated.
- •-Bilateral upper-limb paresis, paralysis or tetraparesis.
- •-Surgery in the target limb for any indication within the 8 weeks before screening or within the screening period.
- •-Any previous and planned surgical treatment for spasticity in the target muscle(s).
- •-Severe atrophy of the target limb muscles.
- •-Any previous or planned treatment with phenol- or alcohol-injection into the target limb, as well as any planned treatment with phenol- or alcohol-injection in any body region scheduled for any time during the study.
- •-Treatment with parenterally administered drugs that interfere with neuromuscular transmission, aminoquinolines, or local anesthetics in the treated region within the two weeks before screening, within the screening period, and/or intended to be administered during the study.
- •-Antispastic medication with peripheral muscle relaxants administered within the two weeks before screening, within the screening period, or intended to be administered during the study.
研究者
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