Clinical trial NCT04407377: Effects of Tolperisone on Measures of Drowsiness and Cognitive Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Neurana Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-29
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Driving Performance
timeFrame: Day 1
Secondary outcomes:
measure: Karolinska Sleepiness Scale
timeFrame: Day 1
measure: Epworth Sleepiness Scale
timeFrame: Day 3
measure: Reaction Time
timeFrame: Day 1
measure: Rapid Visual Information Processing
timeFrame: Day 1
measure: CogScreen Symbol Digit Coding Test
timeFrame: Day 1
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: CNS Trial
state: California
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
Study officials:
References: