NCT03353922

Driving Simulation to Assess Non-Sedative Effects of Tolperisone

Driving Simulation Cross-Over Study of Sedative Effects of Tolperisone Compared to Cyclobenzaprine and Placebo

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Neurana Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized blinded study to assess the sedative effect of 150 mg TID tolperisone and 10 mg TID cyclobenzaprine compared to placebo on simulated driving performance and cognitive functioning in healthy adult volunteers.

Detailed description

This will be a randomized, placebo-controlled, multiple-dose 3-way cross-over study of the safety and cognitive effects of multiple doses of 150 mg tolperisone administered TID in 30 male and female healthy volunteers. Treatment groups include 450 mg tolperisone (i.e., 150 mg administered three times daily), 30 mg cyclobenzaprine (i.e., 10 mg administered three times daily), and placebo. Subjects will receive 3 days of each treatment. Subject participation will be approximately 3 weeks as outpatients with 3 days each week as overnight clinic participants. In this crossover study, treatment effects will be assessed following the second initial dose, the morning following nighttime dosing (to assess residual next day effects), and at steady state (i.e., following AM dosing on Day 3). Subjects will be dosed on the morning of Day 1. Approximately one hour after the second dose on Day 1, subjects will be administered the cognitive test, followed by the driving simulator examination. On the morning of Day 2, prior to dosing, subjects will be readministered the cognitive test and driving examination to assess residual next day effects. Subjects will repeat cognitive testing and the driving examination on the morning of Day 3, after administration of the AM study medication, to evaluate the cumulative effects of 3 days of dosing.

Conditions

• Driving Impaired

Interventions

Type	Name	Description
DRUG	Cyclobenzaprine 10 Mg Oral Tablet	cyclobenzaprine 10 mg tablets
DRUG	Placebo Oral Tablet	sugar pill

Timeline

• Start date: 2017-07-31
• Primary completion: 2017-12-06
• Completion: 2018-01-30
• First posted: 2017-11-27
• Last updated: 2022-02-01
• Results posted: 2020-10-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study