A Randomized, 4-Period, Crossover Study to characterize the effects of tolperisone 200 mg and 400 mg (supratherapeutic dose) three times a day (TID) over 3 days of dosing on measures of simulated driving performance, cognitive function and drowsiness and compared to placebo and cyclobenzaprine (single-day, residual effect, multiple-day).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
CNS Trial
Long Beach, California, United States
Hassman Research Institute
Berlin, New Jersey, United States
Driving Performance
Standard Deviation of Lateral Position, measured by simulated driving performance using Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim), of tolperisone compared to placebo
Time frame: Day 1
Karolinska Sleepiness Scale
Measure of Drowsiness
Time frame: Day 1
Epworth Sleepiness Scale
Measure of Drowsiness
Time frame: Day 3
Reaction Time
Measure of Cognitive Function
Time frame: Day 1
Rapid Visual Information Processing
Measure of Cognitive Function
Time frame: Day 1
CogScreen Symbol Digit Coding Test
Measure of Cognitive Function
Time frame: Day 1
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