Driving ImpairedPhase 1NCT03353922
Driving Simulation to Assess Non-Sedative Effects of Tolperisone
A Phase 1 study testing Cyclobenzaprine 10 Mg Oral Tablet in people with Driving Impaired, run by Neurana Pharmaceuticals, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Driving Impaired
- What is being tested?
- Cyclobenzaprine 10 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2017to 30 Jan 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- Subjects who consume excessive amounts of coffee, tea, cola, or other caffeinated beverages per day. Excessive amount is defined as greater than 6 servings per day (where 1 serving is approximately equivalent to 120 mg of caffeine).
- Subjects who will be working a night shift within 1 week of a visit.
- Subject who have traveled across 1 or more time zones (transmeridian travel) in the last 2 weeks prior to randomization or is expected to travel across 1 or more time zones during the study.
- Current smoker (>10 cigarettes or eCigarettes, 3 cigars, or 3 pipes per day) and unwilling to refrain from smoking while confined to the CRU for periods of 3 days.
- Subjects who have an inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee.
- Subjects who are a staff member or relative of a staff member.
- Inability or unwillingness to use adequate contraception (as defined in item 10 of the Inclusion Criteria) during and for 1 month following completion of the study.
- Has a positive screen for alcohol or other drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NeuroTrials Research
Atlanta, Georgia, 30342
Collaborative Neuroscience Network
Long Beach, California, 92845
About this study
Official title: Driving Simulation Cross-Over Study of Sedative Effects of Tolperisone Compared to Cyclobenzaprine and Placebo
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.
Read the detailed description
This will be a randomized, placebo-controlled, multiple-dose 3-way cross-over study of the safety and cognitive effects of multiple doses of 150 mg tolperisone administered TID in 30 male and female healthy volunteers. Treatment groups include 450 mg tolperisone (i.e., 150 mg administered three times daily), 30 mg cyclobenzaprine (i.e., 10 mg administered three times daily), and placebo. Subjects will receive 3 days of each treatment.
Subject participation will be approximately 3 weeks as outpatients with 3 days each week as overnight clinic participants.
In this crossover study, treatment effects will be assessed following the second 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).
Subjects will be dosed on the morning of Day 1. Approximately one hour after the second dose on Day 1, subjects will be administered the cognitive test, followed by the driving simulator examination.
On the morning of Day 2, prior to dosing, subjects will be readministered the cognitive test and driving examination to assess residual next day effects.
Subjects will repeat cognitive testing and the driving examination on the morning of Day 3, after administration of the AM study medication, to evaluate the cumulative effects of 3 days of dosing.
- Conditions
- Driving Impaired
- Being tested
- Cyclobenzaprine 10 Mg Oral Tablet, Placebo Oral Tablet
- Keywords
- cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclobenzaprine 10 Mg Oral TabletDrug
Also called Flexeril
cyclobenzaprine 10 mg tablets
Placebo Oral TabletDrug
Also called tolperisone matching placebo
sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Tolperisone HCl 150 mg | Experimental | 150 mg tolperisone tablets or cyclobenzaprine 10 mg oral tablet administered by mouth every 8 hours for 3 days Receives: 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 Receives: 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 Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
SDLP measured by simulated driving performance of tolperisone compared to placebo on Day 2 prior to morning dosing to determine the next day residual effect or hangover of treatment
Measured: in the morning predose on Day 2 following nighttime dosing
Sleepiness Endpoint Karolinska Sleepiness Scale KSS
assessment of self-reported motivation for driving performance where 1 equals alert and 9 equals extremely sleepy
Measured: at Tmax on Day 1
Steady State Standard Deviation of Lateral Position (SDLP) Day 3
SDLP measured on Day 3 at steady state following 3 days of dosing three times per day to achieve steady state drug concentration and effect on outcomes
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start31 Jul 2017
- Primary completion6 Dec 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Driving ImpairedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- multiple-dose 3-way cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurana Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353922
- Sponsor's protocol ID
- NR115
- Status last verified
- Jan 2022
- First submitted
- 14 Nov 2017
- Last updated
- 1 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Simulation Cross-Over Study of Sedative Effects of Tolperisone Compared to Cyclobenzaprine and Placebo
- ClinicalTrials.gov ID
- NCT03353922
- Acronym / sponsor ID
- NR115
- Conditions
- Driving Impaired
- Keywords
- cognitive function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Neurana Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a randomized, placebo-controlled, multiple-dose 3-way cross-over study of the safety and cognitive effects of multiple doses of 150 mg tolperisone administered TID in 30 male and female healthy volunteers. Treatment groups include 450 mg tolperisone (i.e., 150 mg administered three times daily), 30 mg cyclobenzaprine (i.e., 10 mg administered three times daily), and placebo. Subjects will receive 3 days of each treatment.
Subject participation will be approximately 3 weeks as outpatients with 3 days each week as overnight clinic participants.
In this crossover study, treatment effects will be assessed following the second 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).
Subjects will be dosed on the morning of Day 1. Approximately one hour after the second dose on Day 1, subjects will be administered the cognitive test, followed by the driving simulator examination.
On the morning of Day 2, prior to dosing, subjects will be readministered the cognitive test and driving examination to assess residual next day effects.
Subjects will repeat cognitive testing and the driving examination on the morning of Day 3, after administration of the AM study medication, to evaluate the cumulative effects of 3 days of dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- multiple-dose 3-way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Tolperisone HCl 150 mg | Experimental | Drug: Cyclobenzaprine 10 Mg Oral Tablet, Drug: Placebo Oral Tablet150 mg tolperisone tablets or cyclobenzaprine 10 mg oral tablet administered by mouth every 8 hours for 3 days |
| Placebo Oral Tablet | Placebo comparator | Drug: Cyclobenzaprine 10 Mg Oral Tablet, Drug: Placebo Oral Tabletsugar pills administered by mouth every 8 hours for 3 days |
| Cyclobenzaprine 10 mg oral tablet | Active comparator | Drug: Placebo Oral Tablet10 mg cyclobenzapine tablets administered by mouth every 8 hours for 3 days |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclobenzaprine 10 Mg Oral TabletAlso: Flexerilcyclobenzaprine 10 mg tablets | Drug | Placebo Oral Tablet, Tolperisone HCl 150 mg |
| Placebo Oral TabletAlso: tolperisone matching placebosugar pill | Drug | Cyclobenzaprine 10 mg oral tablet, Placebo Oral Tablet, Tolperisone HCl 150 mg |
Primary outcome
Standard Deviation of Lateral Position (SDLP)
Time frame: at time of peak concentration of drug (Tmax) on Day 1
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).
3 secondary outcomes
Standard Deviation of Lateral Position (SDLP) in Simulated Driving Test of Tolperisone Compared to Placebo on Day 2 Next Day Residual Effect
Time frame: in the morning predose on Day 2 following nighttime dosing
Sleepiness Endpoint Karolinska Sleepiness Scale KSS
Time frame: at Tmax on Day 1
Steady State Standard Deviation of Lateral Position (SDLP) Day 3
Time frame: Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclobenzaprine 10 Mg Oral Tablet in people with Driving Impaired, run by Neurana Pharmaceuticals, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Deviation of Lateral Position (SDLP) (time frame: at time of peak concentration of drug (Tmax) on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.