Effect of Metaxalone 640 mg (M640) on Driving, Cognition, and EEG Dynamics Compared to Tizanidine 8 mg in Adults
Assessment of the Effect of Metaxalone Tablets, 640 mg (M640) on Driving Ability, Cognition, and Electroencephalographic (EEG) Dynamics Compared to Tizanidine 8 mg in Adult Participants: A Prospective, Single-blind, Within-subject Study
Participant takes a single pill after eating, takes a driving test on a simulator, takes thought and concentration computerized tests
研究概览
详细说明
The study evaluates effects of a single-dose of M640 mg compared to a single dose of tizanidine 8 mg on driving, cognition, sleepiness, and brain activity in healthy adults
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：James Lukban, D.O.
- 电话号码：480-483-1410
- 邮箱：jlukban@primusrx.com
研究联系人备份
- 姓名：Manar Shahbandar
- 电话号码：4804831410
- 邮箱：mshahbandar@primusrx.com
学习地点
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Arizona
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Scottsdale、Arizona、美国、85253
- Perseverance Research Center, LLC
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首席研究员：
- Allan Block, MD
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接触：
- Nicole C Hank
- 电话号码：4804716132
- 邮箱：nhank@prcresearcheducation.com
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接触：
- Laura Christians
- 电话号码：4804716132
- 邮箱：lchristians@prcresearcheducation.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults, aged ≥ 18 and ≤ 65 years of age at the time of consent.
- Weigh at least 120 pounds at Screening/Baseline and Baseline.
- Medically healthy
- Able to take oral medication.
- Possesses a valid driver's license.
Exclusion Criteria:
- Current use of any medications known to affect sleep-wake cycle.
- Has a sleep disorder.
- Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids
- Known history of alcohol or substance use disorder
- Participants with a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia.
- Participants with a history of seizure disorder or epilepsy.
- Participants with scalp conditions, dermatologic disease, or hair/scalp characteristics
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Active metaxalone 640 mg
metaxalone 640 mg tablets, one dose only |
micronized metaxalone 640 mg pill
其他名称：
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有源比较器：Active tizanidine 8 mg
tizanidine 8 mg tablets, one dose only |
muscle relaxer for spasms
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 |
|---|---|---|
|
Change from Baseline to Tmax in Standard Deviation of Lateral Position as evaluated by Driving Simulation Software
大体时间：Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
A hardware and software setup that recreates the experience of driving a real vehicle and measures performance at the time of maximum concentration of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) |
Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
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Change from Baseline to Tmax in Cognition as assessed by Creyos Cognitive Testing (CCT).
大体时间：Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
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Computerized thinking assessment to objectively measure brain function at the time of maximum concentration of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) |
Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline to Tmax in Degree of point-in-time drowsiness as measured by the Karolinska Sleepiness Scale (KSS).
大体时间：Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours
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Measure at Tmax (metaxalone 4 hours and tizanidine 1.5 hours post dose) Scale: 1 = Extremely alert, 2 = Very alert, 3 = Alert, 4 = Rather alert, 5 = Neither alert nor sleepy, 6 = Some signs of sleepiness, 7 = Sleepy, but no effort to keep awake, 8 = Sleepy, some effort to keep awake, 9 = Very sleepy, great effort to keep awake, fighting sleep |
Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours
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Change from Baseline to Tmax in electroencephalograph measures
大体时间：Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
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Placement of a non-invasive headset with saline filled, padded electrodes on the participant's scalp to measure brain activity with eyes open and closed at the time of maximum dose of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) |
Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose
|
合作者和调查者
调查人员
- 研究主任：James Lukban, DO、Primus Pharmaceuticals, Inc.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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