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Driving Simulation to Assess Non-Sedative Effects of Tolperisone

NCT03353922 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-02-01

Study results available
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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.

Conditions

  • Driving Impaired

Interventions

DRUG

Cyclobenzaprine 10 Mg Oral Tablet

cyclobenzaprine 10 mg tablets

DRUG

Placebo Oral Tablet

sugar pill

Sponsors & Collaborators

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • Neurana Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2017-12-06
Completion
2018-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03353922 on ClinicalTrials.gov