Effect of Metaxalone 640 mg (M640) on Driving, Cognition, and EEG Dynamics Compared to Tizanidine 8 mg in Adults
NCT07932613, Phase 4, Not yet recruiting, Primus Pharmaceuticals
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Metaxalone 640 mg (M640) on Driving, Cognition, and EEG Dynamics Compared to Tizanidine 8 mg in Adults | ClinicalTrials.gov |
| NCT number | NCT07932613 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Primus Pharmaceuticals | ClinicalTrials.gov |
| Conditions | Healthy Participant | ClinicalTrials.gov |
| Interventions | Metaxalone Pill, tizanidine 8 mg | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from Baseline to Tmax in Standard Deviation of Lateral Position as evaluated by Driving Simulation Software | Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose | A hardware and software setup that recreates the experience of driving a real vehicle and measures performance at the time of maximum concentration of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) | ClinicalTrials.gov |
| Primary | Change from Baseline to Tmax in Cognition as assessed by Creyos Cognitive Testing (CCT). | Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose | Computerized thinking assessment to objectively measure brain function at the time of maximum concentration of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) | ClinicalTrials.gov |
| Secondary | Change from Baseline to Tmax in Degree of point-in-time drowsiness as measured by the Karolinska Sleepiness Scale (KSS). | Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours | Measure at Tmax (metaxalone 4 hours and tizanidine 1.5 hours post dose) Scale: 1 = Extremely alert, 2 = Very alert, 3 = Alert, 4 = Rather alert, 5 = Neither alert nor sleepy, 6 = Some signs of sleepiness, 7 = Sleepy, but no effort to keep awake, 8 = Sleepy, some effort to keep awake, 9 = Very sleepy, great effort to keep awake, fighting sleep | ClinicalTrials.gov |
| Secondary | Change from Baseline to Tmax in electroencephalograph measures | Baseline dose to time of maximum concentration (Tmax), metaxalone 4 hours and tizanidine 1.5 hours post dose | Placement of a non-invasive headset with saline filled, padded electrodes on the participant's scalp to measure brain activity with eyes open and closed at the time of maximum dose of the drug in the body (metaxalone 4 hours and tizanidine 1.5 hours post dose) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)