Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407377
• Other study ID #: CLN-116
• Status: Completed
• Phase: Phase 1
• Start date: June 20, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2022
• Source: Neurana Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 31, 2021
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Sleepiness

Intervention

Drug:
• Tolperisone Hydrochloride
Study Drug
• Cyclobenzaprine Hydrochloride 10 MG
Active Comparator

Other:
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
United States	Hassman Research Institute	Berlin	New Jersey
United States	CNS Trial	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurana Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1
Secondary	Karolinska Sleepiness Scale	Measure of Drowsiness	Day 1
Secondary	Epworth Sleepiness Scale	Measure of Drowsiness	Day 3
Secondary	Reaction Time	Measure of Cognitive Function	Day 1
Secondary	Rapid Visual Information Processing	Measure of Cognitive Function	Day 1
Secondary	CogScreen Symbol Digit Coding Test	Measure of Cognitive Function	Day 1