Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    Neurana Pharmaceuticals, Inc.
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Updated on 5 August 2020
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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).

Details
Condition Healthy
Age 21years - 65years
Treatment Placebo, Tolperisone Hydrochloride, Cyclobenzaprine Hydrochloride 10 MG
Clinical Study IdentifierNCT04407377
SponsorNeurana Pharmaceuticals, Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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