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Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

NCT04407377 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-02-01

No results posted yet for this study

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

DRUG

Tolperisone Hydrochloride

Study Drug

DRUG

Cyclobenzaprine Hydrochloride 10 MG

Active Comparator

OTHER

Placebo

Placebo Comparator

Sponsors & Collaborators

  • Neurana Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-06-20
Primary Completion
2020-10-16
Completion
2021-03-31
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 NCT04407377 on ClinicalTrials.gov