A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
2021年2月17日 更新者：XenoPort, Inc.
Multiple-Dose Efficacy and Safety Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury
The purpose of this study is to evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with spasticity due to spinal cord injury
研究概览
地位
完全的
条件
详细说明
This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury.
Three cohorts of subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30 mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment segment.
Each subject serves as their own control in this cross-over study.
研究类型
介入性
注册 (实际的)
37
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Downey、California、美国
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Gilroy、California、美国
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Pasadena、California、美国
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San Jose、California、美国
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Colorado
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Englewood、Colorado、美国
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Florida
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Miami、Florida、美国
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Georgia
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Atlanta、Georgia、美国
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Illinois
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Chicago、Illinois、美国
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Kansas
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Kansas City、Kansas、美国
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Michigan
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Ann Arbor、Michigan、美国
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Detroit、Michigan、美国
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Spasticity secondary to traumatic spinal cord injury between C-5 and T-12 spinal cord levels, at least 12 months post-injury with a stable neurological deficit
Exclusion Criteria:
- Traumatic brain injury or cognitive deficit of any etiology that may influence compliance with study procedures or outcome measures
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：XP19986 SR1 10 mg - Placebo
Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 10 mg BID treatment crossing over to placebo treatment (or the reverse order).
Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
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XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
其他名称：
Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods.
Also taken during placebo washout periods.
其他名称：
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实验性的：XP19986 SR1 20 mg - Placebo
Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 20 mg BID treatment crossing over to placebo treatment (or the reverse order).
Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
|
Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods.
Also taken during placebo washout periods.
其他名称：
XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
其他名称：
|
|
实验性的：XP19986 SR1 30 mg - Placebo
Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 30 mg BID treatment crossing over to placebo treatment (or the reverse order).
Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.
|
Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods.
Also taken during placebo washout periods.
其他名称：
XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum Ashworth score
大体时间：Day 17
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Ashworth score for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose.
Evaluate the difference in the primary endpoint between active and placebo treament segments at 17th day of dosing in each segment
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Day 17
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Average Ashworth score
大体时间：Day 17
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This was the average of Ashworth scores obtained on Day 17 of dosing across 6 muscle groups for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose
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Day 17
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Two Highest Ashworth scores
大体时间：Day 17
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This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had the 2 highest Ashworth scores at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose
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Day 17
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Average Non-zero Ashworth Scores
大体时间：Day 17
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This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had a non-zero Ashworth score at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose
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Day 17
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Michael Leong, M.D.、XenoPort, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年12月1日
初级完成 (实际的)
2009年4月1日
研究完成 (实际的)
2009年4月1日
研究注册日期
首次提交
2007年11月12日
首先提交符合 QC 标准的
2007年11月12日
首次发布 (估计)
2007年11月14日
研究记录更新
最后更新发布 (实际的)
2021年2月21日
上次提交的符合 QC 标准的更新
2021年2月17日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
XP19986 SR1, 10 mg BID的临床试验
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