Healthy ParticipantsPhase 4NCT06348303
Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg
A Phase 4 study testing Metaxalone m640 mg oral tablet and Metaxalone 800 mg oral tablet in people with Healthy Participants, run by Primus Pharmaceuticals at 1 site in United States.
Trial summary
Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Metaxalone m640 mg oral tablet and Metaxalone 800 mg oral tablet
- 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
- 16 May 2024to 30 Oct 2024
- Phase
- Phase 4
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weigh at least 120 pounds at Screening
- Medically healthy with no clinically significant medical co-morbidities impact endpoints
Who cannot join
- Current use of any medications known to affect sleep-wake cycle.
- Known sleep disorder.
- Current use of cimetidine.
- Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5- hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol).
- Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids.
- Participants taking skeletal muscle relaxants or sedative hypnotics.
- Participants with gastrointestinal disease affecting absorption.
- Participants with severe hepatic or renal impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Single-blind, Pilot Study to Assess Drowsiness, Cognition, and Fall Risk Following Oral Metaxalone 640 mg (M640) Versus Metaxalone 800 mg in Healthy Subjects"
Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.
Read the detailed description
The Screening-Baseline Visit will include vital signs and urine testing, and a discussion of medications and current medical history. Participants will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk.
Visit 2 approximately one to two (1 to 2) week(s) later will be the first dosing day (Arm 1) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.
Visit 3 approximately one (1) week later will be the second dosing day (Arm 2) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.
The End of Study safety visit will take place one (1) week after Visit 3 by phone with a discussion of any side effects from the drug, recent medications, and any illness or injury experienced since the previous visit. Participants will be given end of study and discharge instructions.
- Conditions
- Healthy Participants
- Being tested
- Metaxalone m640 mg oral tablet, Metaxalone 800 mg oral tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metaxalone m640 mg oral tabletDrug
Also called m640
Metaxalone partially micronized 640 mg tablet
Metaxalone 800 mg oral tabletDrug
Also called Skelaxin
Metaxalone non-micronized 800 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Active 640 mg | Active comparator | Metaxalone (M640) 640 mg tablet, a single-dose at visit 2 of 4 visits. Receives: Drug: Metaxalone m640 mg oral tablet |
| Active 800 mg | Active comparator | Metaxalone 800 mg tablet, a single-dose at Visit 3 of 4 visits. Receives: Drug: Metaxalone 800 mg oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).
Validated 4-Stage Balance Test after completion of an FDA standardized high-fat meal. Place one foot in front of the other, heel touching toes.
Measured: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path
Timed Up and Go with Triaxial Accelerometry
Measured: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path
Tandem Walk Test
Measured: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Secondary outcomes (4)
Change from baseline of participants' subjective report of drowsiness on a 10-point scale
Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake
Measured: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds
Reaction Time Test (RTT)
Measured: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes
Creyos Cognitive Test
Measured: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
The number of product related adverse events experienced by participants from Visit 2 through Visit 4
Adverse and Serious Adverse Events
Measured: Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start16 May 2024
- Primary completion5 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each participant will be enrolled to two (2), single dose, study treatment arms in a crossover design. The treatments will occur consecutively with seven (7) days separating days of dosing.
- 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
- ClinOhio Research Services, LLC
- Responsible party
- Sponsor
- Investigators
- J Lukban, DO, Study director, Primus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348303
- Sponsor's protocol ID
- PMMD-01
- Status last verified
- Aug 2025
- First submitted
- 30 Mar 2024
- Last updated
- 7 Aug 2025
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blind, Pilot Study to Assess Drowsiness, Cognition, and Fall Risk Following Oral Metaxalone 640 mg (M640) Versus Metaxalone 800 mg in Healthy Subjects"
- ClinicalTrials.gov ID
- NCT06348303
- Acronym / sponsor ID
- PMMD-01
- Conditions
- Healthy Participants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- ClinOhio Research Services, LLC
- Study start
- 16 May 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 4 Apr 2024 (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.
Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.
Detailed description
The Screening-Baseline Visit will include vital signs and urine testing, and a discussion of medications and current medical history. Participants will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk.
Visit 2 approximately one to two (1 to 2) week(s) later will be the first dosing day (Arm 1) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.
Visit 3 approximately one (1) week later will be the second dosing day (Arm 2) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.
The End of Study safety visit will take place one (1) week after Visit 3 by phone with a discussion of any side effects from the drug, recent medications, and any illness or injury experienced since the previous visit. Participants will be given end of study and discharge instructions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each participant will be enrolled to two (2), single dose, study treatment arms in a crossover design. The treatments will occur consecutively with seven (7) days separating days of dosing.
| Arm | Type | Receives |
|---|---|---|
| Active 640 mg | Active comparator | Drug: Metaxalone m640 mg oral tabletMetaxalone (M640) 640 mg tablet, a single-dose at visit 2 of 4 visits. |
| Active 800 mg | Active comparator | Drug: Metaxalone 800 mg oral tabletMetaxalone 800 mg tablet, a single-dose at Visit 3 of 4 visits. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Weigh at least 120 pounds at Screening
- Medically healthy with no clinically significant medical co-morbidities impact endpoints
Key exclusion criteria (8 listed)
- Current use of any medications known to affect sleep-wake cycle.
- Known sleep disorder.
- Current use of cimetidine.
- Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5- hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol).
- Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids.
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 mg oral tabletAlso: m640Metaxalone partially micronized 640 mg tablet | Drug | Active 640 mg |
| Metaxalone 800 mg oral tabletAlso: SkelaxinMetaxalone non-micronized 800 mg oral tablet | Drug | Active 800 mg |
Primary outcome
Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Validated 4-Stage Balance Test after completion of an FDA standardized high-fat meal. Place one foot in front of the other, heel touching toes.
Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Timed Up and Go with Triaxial Accelerometry
Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Tandem Walk Test
4 secondary outcomes
Change from baseline of participants' subjective report of drowsiness on a 10-point scale
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes
Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)
The number of product related adverse events experienced by participants from Visit 2 through Visit 4
Time frame: Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15)
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 7 Aug 2025.
- 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.
J Lukban, DO study director
Primus Pharmaceuticals, Inc.
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 oral tablet and Metaxalone 800 mg oral tablet in people with Healthy Participants, 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 2 inclusion and 8 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 7 Aug 2025. 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?
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?
Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test). (time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)). 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 7 Aug 2025.