Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

NCT04407377 | Completed Phase 1 FDA Drug

• 1 other identifier: CLN-116
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Karolinska Sleepiness Scale

  Day 1

• Epworth Sleepiness Scale

  Day 3

• Reaction Time

  Day 1

• Rapid Visual Information Processing

  Day 1

• CogScreen Symbol Digit Coding Test

  Day 1

Study Arms (4)

Tolperisone 200 mg

EXPERIMENTAL

Study Drug, Tolperisone 200mg TID

Drug: Tolperisone Hydrochloride

Tolperisone 400 mg

EXPERIMENTAL

Study Drug, Tolperisone 400mg TID

Drug: Tolperisone Hydrochloride

Cyclobenzaprine

ACTIVE COMPARATOR

Active Comparator, Cyclobenzaprine 10mg TID

Drug: Cyclobenzaprine Hydrochloride 10 MG

Placebo

PLACEBO COMPARATOR

Placebo, TID

Other: Placebo

Interventions

Tolperisone Hydrochloride DRUG

Study Drug

Also known as: Tolperisone

Tolperisone 200 mg; Tolperisone 400 mg

Cyclobenzaprine Hydrochloride 10 MG DRUG

Active Comparator

Cyclobenzaprine

Placebo OTHER

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurana Pharmaceuticals, Inc.: lead

Study Sites (2)

CNS Trial

Long Beach, California, 90806, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

MeSH Terms

Interventions

Tolperisone; cyclobenzaprine

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 29, 2020
• Study Start: June 20, 2020
• Primary Completion: October 16, 2020
• Study Completion: March 31, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)