Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03353922
Study type Interventional
Source Neurana Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date July 31, 2017
Completion date January 30, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT06059677 - Cannabis Consumption and Driving Impairment Assessment on a Closed Course Phase 2
Enrolling by invitation NCT05537116 - Evaluation of an Interactive Mobile Phone-Based Brief Intervention to Reduce Substance-Impaired Driving N/A
Completed NCT03169855 - Validation of Mesopic and Photopic Contrast Vision Tests With Respect to Nighttime Driving Ability
Recruiting NCT06111989 - Fitness to Drive Among Stroke Patients
Completed NCT04587609 - Reducing Cell Phone Use While Driving Among High Risk UBI Auto Policy Holders N/A
Completed NCT03656029 - Dose-response of Cannabis and Driving Phase 2
Completed NCT04330196 - Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance. N/A
Completed NCT04948385 - Driving Performance After Deep Sedation for Outpatient Endoscopy Phase 4
Completed NCT03335735 - Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving N/A
Not yet recruiting NCT05703360 - Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance N/A
Active, not recruiting NCT03581058 - Neural Correlates of Driving and Cannabis Phase 1
Withdrawn NCT05273658 - Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests Phase 1/Phase 2
Completed NCT04648735 - Driving Evaluation and Fitness for Persons With Cognitive Impairments N/A
Completed NCT03195608 - Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease N/A