Clinical trial: Effects of Tolperisone on Measures of Drowsiness and Cognitive Function (NCT04407377)

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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 25-year-old woman comes to the clinic with her roommate.  The roommate says that the patient has twice fallen asleep while they were talking.  The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap.  She also reveals that she sometimes hears a voice prior to falling asleep.  She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately.

Patient description (patient's own words): I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep.

Does the patient match the trial criteria? 0