A Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults (REHAB-1)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 19
- 主要终点
- Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4
研究概览
简要总结
This is a randomized, double-blind, multi-center phase II/III study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults
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)
盲法说明
Double-blind
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 randomized 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).
- •If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
- •If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.
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 randomized 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 randomized enrollment.
研究组 & 干预措施
Treatment Group
Single 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)
Active-Controlled Group
Single injection with BOTOX® in upper limb spasticity
干预措施: BOTOX® (Biological)
Placebo-Controlled Group
Single injection with placebo in upper limb spasticity
干预措施: Placebo (Biological)
结局指标
主要结局
Change From Baseline in Modified Ashworth Scale (MAS) Score of Primary Target Clinical Pattern at Week 4
时间窗: Week 4 after treatment
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed elbow or flexed wrist or clenched fist. The Modified Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 6-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
次要结局
- Physician's Global Assessment (PGA) Score at Week 1, Week 4, Week 8 and Week 12(Week 1, Week 4, Week 8 and Week 12 after treatment)
- Change From Baseline in MAS Score of Primary Target Clinical Pattern at Week 1, Week 8, Week 12(Week 1, Week 8 and Week 12 after treatment)
- Response Rates on MAS Calculated for the Primary Target Clinical Pattern at Week 1, Week 4, Week 8 and Week 12(Week 1, Week 4, Week 8 and Week 12 after treatment)
- Changes From Baseline in Disability Assessment Scale (DAS)- Principal Therapeutic Target Domain at Week 1, Week 4, Week 8 and Week 12(Week 1, Week 4, Week 8 and Week 12 after treatment)
- Incidence of Adverse Events and Serious Adverse Events(Within 12 weeks of treatment)
- Incidence of Anti-drug Antibodies and Neutralizing Antibodies(Within 12 weeks of treatment)