A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Recombinant Botulinum Toxin Type A (JHM03) in Adult Patients With Upper Limb Spasticity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 20
- 主要终点
- The incidence rate of adverse events and severe adverse events
研究概览
简要总结
This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A（JHM03）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.
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-blinded
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent
- •Body weight ≥50Kg
- •Participants with stable post-stroke Spasticity (ULS) for at least 3 months
- •Participants with Modified Ashworth Scale (MAS) score of at least 2 at elbow flexor or wrist flexor or finger flexor
- •Participants with DAS score of at least 2 on the Principal Target of Treatment (PTT) (one of four functional domains: dressing, hygiene, limb position and pain)
- •Participants who have been stable for at least 1 month prior to study entry in terms of oral antispasticity
排除标准
- •Previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study.
- •History of alcohol or drug abuse.
- •Known allergy or hypersensitivity to any component of the study products.
- •History of epilepsy
- •Known or suspected to be HIV positive, serologically positive for syphilis, or active hepatitis B or C
- •Any medical condition that may put the participant at increased risk for botulinum toxin type A use
研究组 & 干预措施
Experimental Group 1
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
干预措施: Sequence 1 (Drug)
Experimental Group 2
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
干预措施: Sequence 2 (Drug)
Experimental Group 3
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
干预措施: Sequence 3 (Drug)
Experimental Group 4
Participants will receive one cycle of JHM03 in the selected overactive upper limb muscles
干预措施: Sequence 4 (Drug)
Placebo Group
Participants will receive one cycle of Placebo in the selected overactive upper limb muscles
干预措施: Sequence 5 (Drug)
结局指标
主要结局
The incidence rate of adverse events and severe adverse events
时间窗: Within 12 weeks
The incidence rate of adverse events and severe adverse events within 12 weeks after injection;
Change from baseline at week 4 for primary targeted muscle group on the MAS
时间窗: Within 4 weeks
Change from baseline at week 4 for primary targeted muscle group on the MAS(Modified Ashworth Scale).
次要结局
未报告次要终点