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Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tolperisone Hydrochloride

Cyclobenzaprine Hydrochloride 10 MG

Placebo

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Ambulatory male or female, between 21 and 65 years of age, inclusive, for the entire duration of the study (from Screening through Day 3 of last treatment period).
Body mass index (BMI) range between 18.5 and 30.0 kg/m2, inclusive.
Subject must possess a valid driver's license and be an active driver and have driven a minimum of 10,000 miles (about 16,000 km) per year for the previous 3 years.
Subject must demonstrate simulator sickness questionnaire scores that are not indicative of simulator sickness as defined in the driving simulation operations manual.
Subject must have a regular sleep pattern, not be engaged in shift-work, and in general, have at least 7 hours of sleep each night.

Exclusion Criteria:

History of sleep disorders, including insomnia, sleep apnea, Restless Legs Syndrome (RLS), or narcolepsy, night-shift workers, routine daytime napping or oversleeping on weekends days (off work) or a score higher than 10 on the Epworth Sleepiness Scale (ESS) at Screening.
A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the Investigator.
Subject has traveled across 2 or more time zones (trans meridian travel) in the last 2 weeks prior to randomization or is expected to travel across 2 or more time zones during the study.
Subject has any physical condition (e.g., severe vision issues, hand use limitations) that would prevent the subject from performing the cognitive or drowsiness assessments.
Subject has a presence or history of any medically diagnosed, clinically significant psychiatric disorder, including depression, anxiety, insomnia, schizophrenia, or bipolar disorder.
Consumes more than 3 cups of coffee per day.
Female subjects who are pregnant or lactating.
Any clinically significant medical abnormality, any clinically significant chronic disease, or any clinically significant finding on physical examination.
Subject with a genotype status of poor-, ultrarapid-, or indeterminate- metabolizers of cytochrome CYP2D6.
Subject is unable to remain in the research unit for each of the treatment periods.
Subject has visual or auditory impairment which in the opinion of the Investigator would interfere with study related procedures or study conduct.

Sites / Locations

CNS Trial
Hassman Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Tolperisone 200 mg

Tolperisone 400 mg

Cyclobenzaprine

Placebo

Arm Description

Study Drug, Tolperisone 200mg TID

Study Drug, Tolperisone 400mg TID

Active Comparator, Cyclobenzaprine 10mg TID

Placebo, TID

Outcomes

Primary Outcome Measures

Driving Performance

Standard Deviation of Lateral Position, measured by simulated driving performance using Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim), of tolperisone compared to placebo

Secondary Outcome Measures

Karolinska Sleepiness Scale

Measure of Drowsiness

Epworth Sleepiness Scale

Measure of Drowsiness

Reaction Time

Measure of Cognitive Function

Rapid Visual Information Processing

Measure of Cognitive Function

CogScreen Symbol Digit Coding Test

Measure of Cognitive Function

Full Information

NCT ID

NCT04407377

First Posted

May 7, 2020

Last Updated

January 28, 2022

Sponsor

Neurana Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04407377

Brief Title

Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

June 20, 2020 (Actual)

Primary Completion Date

October 16, 2020 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neurana Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tolperisone 200 mg

Arm Type

Experimental

Arm Description

Study Drug, Tolperisone 200mg TID

Arm Title

Tolperisone 400 mg

Arm Type

Experimental

Arm Description

Study Drug, Tolperisone 400mg TID

Arm Title

Cyclobenzaprine

Arm Type

Active Comparator

Arm Description

Active Comparator, Cyclobenzaprine 10mg TID

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo, TID

Intervention Type

Drug

Intervention Name(s)

Tolperisone Hydrochloride

Other Intervention Name(s)

Tolperisone

Intervention Description

Study Drug

Intervention Type

Drug

Intervention Name(s)

Cyclobenzaprine Hydrochloride 10 MG

Intervention Description

Active Comparator

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo Comparator

Primary Outcome Measure Information:

Title

Driving Performance

Description

Standard Deviation of Lateral Position, measured by simulated driving performance using Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim), of tolperisone compared to placebo

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Karolinska Sleepiness Scale

Description

Measure of Drowsiness

Time Frame

Day 1

Title

Epworth Sleepiness Scale

Description

Measure of Drowsiness

Time Frame

Day 3

Title

Reaction Time

Description

Measure of Cognitive Function

Time Frame

Day 1

Title

Rapid Visual Information Processing

Description

Measure of Cognitive Function

Time Frame

Day 1

Title

CogScreen Symbol Digit Coding Test

Description

Measure of Cognitive Function

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ambulatory male or female, between 21 and 65 years of age, inclusive, for the entire duration of the study (from Screening through Day 3 of last treatment period). Body mass index (BMI) range between 18.5 and 30.0 kg/m2, inclusive. Subject must possess a valid driver's license and be an active driver and have driven a minimum of 10,000 miles (about 16,000 km) per year for the previous 3 years. Subject must demonstrate simulator sickness questionnaire scores that are not indicative of simulator sickness as defined in the driving simulation operations manual. Subject must have a regular sleep pattern, not be engaged in shift-work, and in general, have at least 7 hours of sleep each night. Exclusion Criteria: History of sleep disorders, including insomnia, sleep apnea, Restless Legs Syndrome (RLS), or narcolepsy, night-shift workers, routine daytime napping or oversleeping on weekends days (off work) or a score higher than 10 on the Epworth Sleepiness Scale (ESS) at Screening. A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the Investigator. Subject has traveled across 2 or more time zones (trans meridian travel) in the last 2 weeks prior to randomization or is expected to travel across 2 or more time zones during the study. Subject has any physical condition (e.g., severe vision issues, hand use limitations) that would prevent the subject from performing the cognitive or drowsiness assessments. Subject has a presence or history of any medically diagnosed, clinically significant psychiatric disorder, including depression, anxiety, insomnia, schizophrenia, or bipolar disorder. Consumes more than 3 cups of coffee per day. Female subjects who are pregnant or lactating. Any clinically significant medical abnormality, any clinically significant chronic disease, or any clinically significant finding on physical examination. Subject with a genotype status of poor-, ultrarapid-, or indeterminate- metabolizers of cytochrome CYP2D6. Subject is unable to remain in the research unit for each of the treatment periods. Subject has visual or auditory impairment which in the opinion of the Investigator would interfere with study related procedures or study conduct.

Facility Information:

Facility Name

CNS Trial

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Hassman Research Institute

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

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