Driving Simulation to Assess Non-Sedative Effects of Tolperisone

Completed · Phase 1 · Has a placebo group

Conditions studied: Driving Impaired

In brief

This is a randomized blinded study to assess the sedative effect of 150 mg TID tolperisone and 10 mg TID cyclobenzaprine compared to placebo on simulated driving performance and cognitive functioning in healthy adult volunteers.

Key facts

Study ID

NCT03353922

Run by

Neurana Pharmaceuticals, Inc.

People needed

35

Starts

2017-07-31

Expected to finish

2018-01-30

Last updated by the study team

2022-02-01

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All healthy volunteer subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).
• All subjects must be capable of understanding and complying with the protocol and have signed the informed consent document. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form.
• Subjects are required to have a body mass index (BMI) of 18 to 32 kg/m2, inclusive, at Screening.
• Subject must be able to reliably perform study assessments (i.e., SDLP no higher than 1 standard deviation greater than the mean for normal healthy adults completing the CVDA practice scenario; and number correct on CogScreen Symbol Digit Coding no less than 1 standard deviation below the mean for healthy adults in the 21-55 year age range); demonstrates the ability to understand task instructions (in English), and be physically capable (e.g., adequate manual dexterity, vision, and hearing), cognitively capable and motivated to perform study tasks.
• 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 also demonstrate simulator sickness questionnaire scores which 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 (bedtime occurs between 21:00 and 24:00 hours).
• Subject has a score < 10 on the Epworth Sleepiness Scale (ESS).
• Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Subjects who have any clinically significant unstable medical abnormality, chronic disease or a history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, or renal systems.
• Subjects who test positive at screening for hepatitis B surface antigen, hepatitis C antibody or have a history of a positive result.
• Subjects who are known to be seropositive or test positive at Screening for Human immunodeficiency virus (HIV).
• Female subjects who are pregnant or lactating.
• Subjects who have a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion.
• A history within 2 years of, or current treatment for a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the subject's sleep.
• A history of difficulty in falling asleep or staying asleep in the previous 3 months, that is considered clinically significant by the investigator.
• Subjects who have a history or diagnosis of any of the following conditions:
• Primary or secondary insomnia
• Narcolepsy
• Cataplexy (familial or idiopathic)
• Circadian Rhythm Sleep Disorder
• Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and rapid eye movement behavior disorder
• Sleep-related Breathing Disorder (obstructive or central sleep apnea syndrome, central alveolar hypoventilation syndrome)
• Periodic Limb Movement Disorder
• Restless Legs Syndrome
• Primary Hypersomnia
• Excessive Daytime Sleepiness (EDS)
• Subject has visual or auditory impairment which in the opinion of the investigator would interfere with study related procedures or study conduct.
• Subjects expected to use any other medication or dietary supplement to promote sleep including over-the-counter sleep medications, during their participation in the study.
• Subjects who have participated in any investigational study within 30 days prior to screening or are currently participating in another clinical trial.
• Subjects who have had a recent history (less than 2 years before entering the study) of drug or alcohol abuse, or current positive urine drug screen. Alcohol abuse is defined as current consumption of more than three alcoholic beverages per day.
• Subjects who have a history of allergic reaction to tolperisone or cyclobenzaprine or any components of these study medications.
• Use of psychoactive prescription or non-prescription medications, psychoactive nutritional supplements or herbal preparations within 2 weeks or 5 half-lives (whichever is longer) of admission to the Clinical Research Unit (CRU) on Day 1.
• Presence of a medical or psychiatric condition which could jeopardize the safety of the subject or validity of study results

Where it is running

• Collaborative Neuroscience Network — Long Beach, California, United States
• NeuroTrials Research — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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