Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Modified Ashworth Scale of the ankle joint
研究概览
简要总结
To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity.
- we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner.
- we also assess the safety of A2NTX and compare it to that of BOTOX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with lower limb spasticity after stroke
- •duration more than 6 months
- •Modified Ashworth Scale of ankle joint more than 2
排除标准
- •patients with previous botulinum toxin injections to lower limbs
- •patients with serious hepatic, renal or cardiac dysfunction
- •patients with respiratory failure
- •patients who cannot understand the instructions
研究组 & 干预措施
A2NTX
single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2
干预措施: A2NTX (Drug)
BOTOX
single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1
干预措施: BOTOX (Drug)
结局指标
主要结局
Change in Modified Ashworth Scale of the ankle joint
时间窗: 30-60 days after injection
Modified Ashworth Scale is measured at baseline, 30(27-33) days and 60 (56-63) days after injection. Area under curve of Modified Ashworth Scale changes at day 30 and day 60 after injection
次要结局
- Change in Functional Independence Measure (FIM)(30 days after injection)
研究者
Ryuji Kaji
Professor and Chairman, Department of Neurology
University of Tokushima