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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
20
Metaxalone partially micronized 640 mg tablet
Metaxalone non-micronized 800 mg oral tablet
ClinOhio Research Institute
Columbus, Ohio, United States
Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).
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.
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path
Timed Up and Go with Triaxial Accelerometry
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path
Tandem Walk Test
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of participants' subjective report of drowsiness on a 10-point scale
Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake
Time frame: 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
Reaction Time Test (RTT)
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes
Creyos Cognitive Test
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
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The number of product related adverse events experienced by participants from Visit 2 through Visit 4
Adverse and Serious Adverse Events
Time frame: Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15)