Cognitive ImpairmentPhase 4NCT06382662
Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition
A Phase 4 study testing metaxalone m640 mg and tizanidine 8mg in people with Cognitive Impairment, run by Primus Pharmaceuticals at 1 site in United States.
Trial summary
Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- metaxalone m640 mg and tizanidine 8mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 6 Mar 2025
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- equal to or greater than 18 years old
- equal to or less than 65 years old
- weight at least 120 pounds
- medically healthy
- able to eat a high fat meal
Who cannot join
- medications known to affect sleep-wake cycle
- current use of cimetidine
- current use of certain anti-depressants
- current use of certain antibiotics
- positive urine drug test for mind altering medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Tizanidine 8 mg: A Prospective, Single-blind, Within-subject Pilot Study
Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.
Read the detailed description
Every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit.
The Screening Visit will be followed by the Baseline (Visit 1) 1-14 days later. At the Baseline Visit participants will be given written tests to measure thinking process. You will also be asked to take a computer driving simulation test.
Visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. The testing from the Baseline Visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug.
The End of Study safety visit will take place two (2) weeks later. Participants will be given discharge instructions.
- Conditions
- Cognitive Impairment
- Being tested
- metaxalone m640 mg, tizanidine 8mg
- Keywords
- Impaired driving
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metaxalone m640 mgDrug
Also called Metaxalone 640
A single dose of micronize metaxalone 640 mg
tizanidine 8mgDrug
Also called Zanaflex
A single dose of tizanidine 8 mg
| Study group | Role | What they receive |
|---|---|---|
| m640 mg | Active comparator | metaxalone micronized 640 mg tablet, single dose Receives: Drug: metaxalone m640 mg; Drug: tizanidine 8mg |
| tizanidine 8 mg | Active comparator | tizanidine 8 mg tablet, single dose Receives: Drug: metaxalone m640 mg; Drug: tizanidine 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline, Standard Deviation of Lateral Position, no Traffic
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Measured: thirty minutes
Change From Baseline, Standard Deviation of Lateral Position, Oncoming Traffic
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Measured: thirty minutes
Change From Baseline, Standard Deviation of Lateral Position, Oncoming Traffic Plus Lead Vehicle
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Measured: thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start29 Apr 2024
- Primary completion30 Dec 2024
- Study completion6 Mar 2025
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 Cognitive ImpairmentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) compared to tizanidine 8 mg in healthy subjects.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Valley Arthritis Center
- Responsible party
- Sponsor
- Investigators
- J C Lukban, DO, Study director, Primus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382662
- Sponsor's protocol ID
- PMDAC-01
- Status last verified
- Sep 2026
- First submitted
- 20 Apr 2024
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Tizanidine 8 mg: A Prospective, Single-blind, Within-subject Pilot Study
- ClinicalTrials.gov ID
- NCT06382662
- Acronym / sponsor ID
- PMDAC-01
- Conditions
- Cognitive Impairment
- Keywords
- Impaired driving
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sun Valley Arthritis Center
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Posted 11 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.
Detailed description
Every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit.
The Screening Visit will be followed by the Baseline (Visit 1) 1-14 days later. At the Baseline Visit participants will be given written tests to measure thinking process. You will also be asked to take a computer driving simulation test.
Visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. The testing from the Baseline Visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug.
The End of Study safety visit will take place two (2) weeks later. Participants will be given discharge instructions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) compared to tizanidine 8 mg in healthy subjects.
| Arm | Type | Receives |
|---|---|---|
| m640 mg | Active comparator | Drug: metaxalone m640 mg, Drug: tizanidine 8mgmetaxalone micronized 640 mg tablet, single dose |
| tizanidine 8 mg | Active comparator | Drug: metaxalone m640 mg, Drug: tizanidine 8mgtizanidine 8 mg tablet, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- equal to or greater than 18 years old
- equal to or less than 65 years old
- weight at least 120 pounds
- medically healthy
- able to eat a high fat meal
Key exclusion criteria (5 listed)
- medications known to affect sleep-wake cycle
- current use of cimetidine
- current use of certain anti-depressants
- current use of certain antibiotics
- positive urine drug test for mind altering medications
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 |
|---|---|---|
| metaxalone m640 mgAlso: Metaxalone 640A single dose of micronize metaxalone 640 mg | Drug | m640 mg, tizanidine 8 mg |
| tizanidine 8mgAlso: ZanaflexA single dose of tizanidine 8 mg | Drug | m640 mg, tizanidine 8 mg |
Primary outcome
Change From Baseline, Standard Deviation of Lateral Position, no Traffic
Time frame: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Change From Baseline, Standard Deviation of Lateral Position, Oncoming Traffic
Time frame: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Change From Baseline, Standard Deviation of Lateral Position, Oncoming Traffic Plus Lead Vehicle
Time frame: thirty minutes
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
J C Lukban, DO study director
Primus Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metaxalone m640 mg and tizanidine 8mg in people with Cognitive Impairment, run by Primus Pharmaceuticals at 1 site 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 5 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 11 Sep 2026). 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?
Change From Baseline, Standard Deviation of Lateral Position, no Traffic (time frame: thirty minutes). The study lists 3 primary outcomes in all. 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 11 Sep 2026.