Driving Simulation to Assess Non-Sedative Effects of Tolperisone

NCT03353922 | Completed Phase 1 Results FDA Drug

• 1 other identifier: NR115
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Driving Impaired

Keywords

cognitive function

Outcome Measures

Primary Outcomes (1)

• Standard Deviation of Lateral Position (SDLP)

  In this crossover study, treatment effects were assessed following initial dose, the morning following nighttime dosing (to assess residual next day effects), and at steady state (i.e., following AM dosing on Day 3).

  at time of peak concentration of drug (Tmax) on Day 1

Secondary Outcomes (3)

• Standard Deviation of Lateral Position (SDLP) in Simulated Driving Test of Tolperisone Compared to Placebo on Day 2 Next Day Residual Effect

  in the morning predose on Day 2 following nighttime dosing

• Sleepiness Endpoint Karolinska Sleepiness Scale KSS

  at Tmax on Day 1

• Steady State Standard Deviation of Lateral Position (SDLP) Day 3

  Day 3

Study Arms (3)

Tolperisone HCl 150 mg

EXPERIMENTAL

150 mg tolperisone tablets or cyclobenzaprine 10 mg oral tablet administered by mouth every 8 hours for 3 days

Drug: Cyclobenzaprine 10 Mg Oral Tablet; Drug: Placebo Oral Tablet

Placebo Oral Tablet

PLACEBO COMPARATOR

sugar pills administered by mouth every 8 hours for 3 days

Drug: Cyclobenzaprine 10 Mg Oral Tablet; Drug: Placebo Oral Tablet

Cyclobenzaprine 10 mg oral tablet

ACTIVE COMPARATOR

10 mg cyclobenzapine tablets administered by mouth every 8 hours for 3 days

Drug: Placebo Oral Tablet

Interventions

Cyclobenzaprine 10 Mg Oral Tablet DRUG

cyclobenzaprine 10 mg tablets

Also known as: Flexeril

Placebo Oral Tablet; Tolperisone HCl 150 mg

Placebo Oral Tablet DRUG

sugar pill

Also known as: tolperisone matching placebo

Cyclobenzaprine 10 mg oral tablet; Placebo Oral Tablet; Tolperisone HCl 150 mg

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Neurana Pharmaceuticals, Inc.: lead
• Cognitive Research Corporation: collaborator

Study Sites (2)

Collaborative Neuroscience Network

Long Beach, California, 92845, United States

Location

NeuroTrials Research

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Interventions

cyclobenzaprine; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Judy Caron, Chief Operating Officer
• Organization: Neurana Pharmaceuticals

jcaron@neuranapharma.com

(617) 640-5043

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: subjects are blindfolded to receive oral dose of treatment, matching placebo, or unblinded active control
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multiple-dose 3-way cross-over study

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 27, 2017
• Study Start: July 31, 2017
• Primary Completion: December 6, 2017
• Study Completion: January 30, 2018
• Last Updated: February 1, 2022
• Results First Posted: October 20, 2020

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)