NCT04407377

Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

A Randomized, 4-Period, Crossover Study to Investigate the Effects of Tolperisone on Measures of Drowsiness and Cognitive Function Compared to Cyclobenzaprine and Placebo

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Neurana Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tolperisone Hydrochloride	Study Drug
DRUG	Cyclobenzaprine Hydrochloride 10 MG	Active Comparator
OTHER	Placebo	Placebo Comparator

Timeline

• Start date: 2020-06-20
• Primary completion: 2020-10-16
• Completion: 2021-03-31
• First posted: 2020-05-29
• Last updated: 2022-02-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study