NCT07478822招募中3 期
An Open-label, Multicenter Clinical Study on The Long-term Safety and Efficacy of Multiple Treatments With Recombinant Botulinum Toxin Type A (YY001) for Injection in Adult Upper Limb Spasticity (REHAB-2)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 16
- 主要终点
- Incidence of Adverse Events and Serious Adverse Events
研究概览
简要总结
This is an open-label, multicenter, phase III clinical study to evaluate the long-term safety and efficacy of multiple treatments with recombinant botulinum toxin type A (YY001) for injection in adult upper limb spasticity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
- •Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to enrollment) exhibiting upper limb spasticity.
- •Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).
排除标准
- •History of allergy to any component of the experimental drugs.
- •Previous use of any botulinum toxin within 6 months prior to enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
- •Fixed contractures of the studied limb.
- •Any medical condition that may increase the risk to the subject when using botulinum toxin type A.
- •Need for treatment with drugs that interfere with neuromuscular function during the study.
- •Plan or anticipate to use new antispasticity drugs during the study.
- •History of epilepsy.
- •Pregnant or breastfeeding women.
- •Participation in other drug/device clinical trials within 1 month prior to enrollment.
研究组 & 干预措施
Recombinant botulinum toxin type A (YY001)
Experimental
Multiple injection with recombinant botulinum toxin type A for injection (YY001) in upper limb spasticity
干预措施: Recombinant botulinum toxin type A for injection (YY001) (Biological)
结局指标
主要结局
Incidence of Adverse Events and Serious Adverse Events
时间窗: Up to 48 weeks
次要结局
- Incidence of Anti-drug Antibodies and Neutralizing Antibodies(Up to 48 weeks)
- Physician's Global Assessment (PGA) Score(Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment)
- Change From Baseline in MAS Score of Primary Target Clinical Pattern(Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment)
- Response Rates on MAS Calculated for the Primary Target Clinical Pattern(Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment)
- The Proportion with Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain Score Reduction of ≥1 Point(Weeks 1, 4, 8, 12, 16, 20 and 24 after each treatment)
研究者
研究点 (16)
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