HealthyPhase 1NCT04407377
Effects of Tolperisone on Measures of Drowsiness and Cognitive Function
A Phase 1 study testing Tolperisone Hydrochloride and Cyclobenzaprine Hydrochloride 10 MG in people with Healthy, run by Neurana Pharmaceuticals, Inc. at 2 sites in United States.
Trial 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 driving performance, cognitive function and drowsiness and compared to placebo and cyclobenzaprine (single-day, residual… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tolperisone Hydrochloride and Cyclobenzaprine Hydrochloride 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jun 2020to 31 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hassman Research Institute
Berlin, New Jersey, 08009
CNS Trial
Long Beach, California, 90806
About this study
Official title: A Randomized, 4-Period, Crossover Study to Investigate the Effects of Tolperisone on Measures of Drowsiness and Cognitive Function Compared to Cyclobenzaprine and Placebo
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 driving performance, cognitive function and drowsiness and compared to placebo and cyclobenzaprine (single-day, residual effect, multiple-day).
- Conditions
- Healthy
- Being tested
- Tolperisone Hydrochloride, Cyclobenzaprine Hydrochloride 10 MG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolperisone HydrochlorideDrug
Also called Tolperisone
Study Drug
Cyclobenzaprine Hydrochloride 10 MGDrug
Active Comparator
PlaceboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Tolperisone 200 mg | Experimental | Study Drug, Tolperisone 200mg TID Receives: Drug: Tolperisone Hydrochloride |
| Tolperisone 400 mg | Experimental | Study Drug, Tolperisone 400mg TID Receives: Drug: Tolperisone Hydrochloride |
| Cyclobenzaprine | Active comparator | Active Comparator, Cyclobenzaprine 10mg TID Receives: Drug: Cyclobenzaprine Hydrochloride 10 MG |
| Placebo | Placebo comparator | Placebo, TID Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Performance
Standard Deviation of Lateral Position, measured by simulated driving performance using Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim), of tolperisone compared to placebo
Measured: Day 1
Secondary outcomes (5)
Karolinska Sleepiness Scale
Measure of Drowsiness
Measured: Day 1
Epworth Sleepiness Scale
Measure of Drowsiness
Measured: Day 3
Reaction Time
Measure of Cognitive Function
Measured: Day 1
Rapid Visual Information Processing
Measure of Cognitive Function
Measured: Day 1
CogScreen Symbol Digit Coding Test
Measure of Cognitive Function
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start20 Jun 2020
- Primary completion16 Oct 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurana Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407377
- Sponsor's protocol ID
- CLN-116
- Status last verified
- Jan 2022
- First submitted
- 7 May 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- 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
- A Randomized, 4-Period, Crossover Study to Investigate the Effects of Tolperisone on Measures of Drowsiness and Cognitive Function Compared to Cyclobenzaprine and Placebo
- ClinicalTrials.gov ID
- NCT04407377
- Acronym / sponsor ID
- CLN-116
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Neurana Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 driving performance, cognitive function and drowsiness and compared to placebo and cyclobenzaprine (single-day, residual effect, multiple-day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tolperisone 200 mg | Experimental | Drug: Tolperisone HydrochlorideStudy Drug, Tolperisone 200mg TID |
| Tolperisone 400 mg | Experimental | Drug: Tolperisone HydrochlorideStudy Drug, Tolperisone 400mg TID |
| Cyclobenzaprine | Active comparator | Drug: Cyclobenzaprine Hydrochloride 10 MGActive Comparator, Cyclobenzaprine 10mg TID |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, TID |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Tolperisone HydrochlorideAlso: TolperisoneStudy Drug | Drug | Tolperisone 200 mg, Tolperisone 400 mg |
| Cyclobenzaprine Hydrochloride 10 MGActive Comparator | Drug | Cyclobenzaprine |
| PlaceboPlacebo Comparator | Other | Placebo |
Primary outcome
Driving Performance
Time frame: Day 1
Standard Deviation of Lateral Position, measured by simulated driving performance using Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim), of tolperisone compared to placebo
5 secondary outcomes
Karolinska Sleepiness Scale
Time frame: Day 1
Epworth Sleepiness Scale
Time frame: Day 3
Reaction Time
Time frame: Day 1
Rapid Visual Information Processing
Time frame: Day 1
CogScreen Symbol Digit Coding Test
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- 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 Tolperisone Hydrochloride and Cyclobenzaprine Hydrochloride 10 MG in people with Healthy, 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 5 inclusion and 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Driving Performance (time frame: 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.