drugset / Trial / NCT04407377
Effects of Tolperisone on Measures of Drowsiness and Cognitive Function
RandomizedCrossoverQuadruple-blindTreatment
Summary
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).
Timeline
- Start
- 2020-06-20
- Primary completion
- 2020-10-16
- Completion
- 2021-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolperisone | Small molecule | 200 mg | — |
| Subject | Tolperisone | Small molecule | 400 mg | — |
| Comparator | cyclobenzaprine | Small molecule | 10 mg | — |
Indications
No indication recorded.