Cognitive Impairment Clinical Trial
Official title:
Assessment of the Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants: A Prospective, Single-blind, Within-subject Pilot Study
Every participant will receive active study drug and (tone) 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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | April 15, 2025 |
Est. primary completion date | April 15, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | 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 cimetadine - current use of certain anti-depressants - current us of certain antibiotics - positive urine drug test for mind altering medications |
Country | Name | City | State |
---|---|---|---|
United States | Sun Valley Arthritis Center | Peoria | Arizona |
Lead Sponsor | Collaborator |
---|---|
Primus Pharmaceuticals | Sun Valley Arthritis Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline, Standard Deviation of Lateral Position | Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software | Baseline, Visit 2 dosing, (day 1), Visit 3 dosing, (day 8) | |
Primary | Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes | Creyos Cognitive Test | Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8) | |
Secondary | 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 | Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8) | |
Secondary | 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. | Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8) | |
Secondary | The number of product related adverse events experienced by participants from Visit 1 through Visit 4 | Adverse and Serious Adverse Events | Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15) |
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