Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neurana Pharmaceuticals, Inc.
• Treatments: Cyclobenzaprine; Tolperisone

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.