Cognitive Impairment
Conditions
Keywords
Impaired driving
Brief summary
Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.
Detailed description
Every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. The Screening Visit will be followed by the Baseline (Visit 1) 1-14 days later. At the Baseline Visit participants will be given written tests to measure thinking process. You will also be asked to take a computer driving simulation test. Visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. The testing from the Baseline Visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug. The End of Study safety visit will take place two (2) weeks later. Participants will be given discharge instructions.
Interventions
DRUGmetaxalone m640
A single dose of micronize metaxalone 640 mg
DRUGtizanidine
A single dose of tizanidine 8 mg
Sponsors
Sun Valley Arthritis Center
Primus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) compared to tizanidine 8 mg in healthy subjects.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* equal to or greater than 20 years old * weight at least 120 pounds * medically healthy * able to eat a high fat meal
Exclusion criteria
* medications known to affect sleep-wake cycle * current use of cimetidine * current use of certain anti-depressants * current us of certain antibiotics * positive urine drug test for mind altering medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline, Standard Deviation of Lateral Position | Baseline, Visit 2 dosing, (day 1), Visit 3 dosing, (day 8) | Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software |
| Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes | Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8) | Creyos Cognitive Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of participants' subjective report of drowsiness on a 10-point scale | Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8) | Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake |
| Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test) | Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (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. |
| The number of product related adverse events experienced by participants from Visit 1 through Visit 4 | Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15) | Adverse and Serious Adverse Events |
Countries
United States
Outcome results
None listed