Efficacy and Safety of SPARC0921 in Subjects With Spasticity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 73
- 主要终点
- Treatment Failure Rate
研究概览
简要总结
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 18 years and older
- •Able and willing to comply with the protocol, including availability for a scheduled clinic visits
- •Willingness and giving of written informed consent
排除标准
- •In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
- •Concomitant neurologic conditions causing spasticity
- •Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
- •Unable to comply with study procedures in the opinion of the investigator
研究组 & 干预措施
SPARC0921
干预措施: SPARC0921 (Drug)
Placebo0921
干预措施: Placebo0921 (Drug)
结局指标
主要结局
Treatment Failure Rate
时间窗: Week 22
Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline. The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension. The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse
次要结局
- Severity of Spasticity Assessed by Subject Global Impression Severity Scale(Week 22)