Status:
COMPLETED
Effects of Tolperisone on Measures of Drowsiness and Cognitive Function
Lead Sponsor:
Neurana Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
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 driv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04407377
Start Date
June 20 2020
End Date
March 31 2021
Last Update
February 1 2022
Active Locations (2)
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1
CNS Trial
Long Beach, California, United States, 90806
2
Hassman Research Institute
Berlin, New Jersey, United States, 08009