A Prospective, Randomized, Single-blind, Pilot Study to Assess Drowsiness, Cognition, and Fall Risk Following Oral Metaxalone 640 mg (M640) Versus Metaxalone 800 mg in Healthy Subjects"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).
研究概览
简要总结
Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.
详细描述
The Screening-Baseline Visit will include vital signs and urine testing, and a discussion of medications and current medical history. Participants will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk.
Visit 2 approximately one to two (1 to 2) week(s) later will be the first dosing day (Arm 1) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.
Visit 3 approximately one (1) week later will be the second dosing day (Arm 2) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.
The End of Study safety visit will take place one (1) week after Visit 3 by phone with a discussion of any side effects from the drug, recent medications, and any illness or injury experienced since the previous visit. Participants will be given end of study and discharge instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Single mask of participants. Participants will be prevented from knowing product dose.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weigh at least 120 pounds at Screening
- •Medically healthy with no clinically significant medical co-morbidities impact endpoints
排除标准
- •Current use of any medications known to affect sleep-wake cycle.
- •Known sleep disorder.
- •Current use of cimetidine.
- •Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5- hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol).
- •Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids.
- •Participants taking skeletal muscle relaxants or sedative hypnotics.
- •Participants with gastrointestinal disease affecting absorption.
- •Participants with severe hepatic or renal impairment.
研究组 & 干预措施
Active 640 mg
Metaxalone (M640) 640 mg tablet, a single-dose at visit 2 of 4 visits.
干预措施: Metaxalone m640 mg oral tablet (Drug)
Active 800 mg
Metaxalone 800 mg tablet, a single-dose at Visit 3 of 4 visits.
干预措施: Metaxalone 800 mg oral tablet (Drug)
结局指标
主要结局
Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).
时间窗: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Validated 4-Stage Balance Test after completion of an FDA standardized high-fat meal. Place one foot in front of the other, heel touching toes.
Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path
时间窗: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Tandem Walk Test
Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path
时间窗: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Timed Up and Go with Triaxial Accelerometry
次要结局
- Change from baseline of participants' subjective report of drowsiness on a 10-point scale(Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8))
- Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds(Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8))
- The number of product related adverse events experienced by participants from Visit 2 through Visit 4(Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15))
- Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes(Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8))