Study of SPARC1103 in Subjects With Spasticity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 23
- 主要终点
- Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
研究概览
简要总结
Study of SPARC1103 in subjects with 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 greater than or equal to 18 years of age
- •Willing to sign the informed consent form
- •Women of child bearing potential willing to practice an acceptable method of birth control
- •Known history of spasticity due to MS
排除标准
- •Administration of an investigational drug or device within 30 days prior to Screening Visit 1
- •Unable to comply with trial procedures in the opinion of the Investigator
- •Concomitant neurologic conditions causing spasticity
- •Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results
研究组 & 干预措施
SPARC 1103 low dose
The subjects will receive SPARC 1103 low dose
干预措施: SPARC1103 low dose (Drug)
SPARC1103 high dose
The subjects will receive SPARC1103 high dose
干预措施: SPARC1103 high dose (Drug)
SPARC Placebo
The subjects will receive SPARC Placebo
干预措施: SPARC Placebo (Drug)
结局指标
主要结局
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
时间窗: Baseline, Day 24
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 in flexion or extension For calculation of modified Ashworth Score, the following scores were assigned to each category of modified Ashworth scale: not testable=NA, 0=0 units, 1=1 unit, 1+ = 2 units, 2 = 3 units, and 4 = 5 units. The total score was the sum of the scores of the 6 lower extremity muscle groups on both left and right sides (range = o0 to 60).
次要结局
- Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score(Baseline, Day 24)
- Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency(Baseline, Day 24)
- Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24(Baseline, Day 24)
- Subject Global Impression of Severity of Spasticity(Baseline, Day 24)