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NCT06382662 · ClinicalTrials.gov registry record · Phase 4
Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition
A Phase 4 study, sponsored by Primus Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT06382662: Completed Phase 4 study, sponsored by Primus Pharmaceuticals.
NCT06382662 is a Phase 4 study that has completed, run by Primus Pharmaceuticals. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06382662, a Phase 4 study, has completed, sponsored by Primus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study 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. There will be ( four (4) visits.
Primary Outcome
Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Interventions
- DRUG metaxalone m640
- DRUG tizanidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-04-29 |
| Est. Completion | 2025-03-06 |
| Phase | Phase 4 |
What the finished NCT06382662 record still lists
NCT06382662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which metaxalone m640 is the first listed.
NCT06382662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06382662 about?
NCT06382662 is a clinical study titled "Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition". 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 v...
What is the current status of trial NCT06382662?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-04-29. Estimated completion is 2025-03-06.
What interventions are being tested in trial NCT06382662?
The interventions under investigation include: metaxalone m640 (DRUG), tizanidine (DRUG).
Who is sponsoring clinical trial NCT06382662?
This trial is sponsored by Primus Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06382662's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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