Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

Sponsor

Neurana Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04407377

Collaborator

(none)

Enrollment

Locations

Arms

9.3

Actual Duration (Months)

19.5

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Tolperisone Hydrochloride Drug: Cyclobenzaprine Hydrochloride 10 MG Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 20, 2020

Actual Primary Completion Date :

Oct 16, 2020

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tolperisone 200 mg Study Drug, Tolperisone 200mg TID	Drug: Tolperisone Hydrochloride Study Drug Other Names: Tolperisone
Experimental: Tolperisone 400 mg Study Drug, Tolperisone 400mg TID	Drug: Tolperisone Hydrochloride Study Drug Other Names: Tolperisone
Active Comparator: Cyclobenzaprine Active Comparator, Cyclobenzaprine 10mg TID	Drug: Cyclobenzaprine Hydrochloride 10 MG Active Comparator
Placebo Comparator: Placebo Placebo, TID	Other: Placebo Placebo Comparator

Outcome Measures

Primary Outcome Measures

Driving Performance [Day 1]
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 [Day 1]
Measure of Drowsiness
Epworth Sleepiness Scale [Day 3]
Measure of Drowsiness
Reaction Time [Day 1]
Measure of Cognitive Function
Rapid Visual Information Processing [Day 1]
Measure of Cognitive Function
CogScreen Symbol Digit Coding Test [Day 1]
Measure of Cognitive Function

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CNS Trial	Long Beach	California	United States	90806
2	Hassman Research Institute	Berlin	New Jersey	United States	08009

Sponsors and Collaborators

Neurana Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neurana Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04407377

Other Study ID Numbers:

CLN-116

First Posted:

May 29, 2020

Last Update Posted:

Feb 1, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleepiness

Cyclobenzaprine

Tolperisone

Study Results

No Results Posted as of Feb 1, 2022