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NCT06348303 · ClinicalTrials.gov registry record · Phase 4
Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg
A Phase 4 study, sponsored by Primus Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT06348303: Completed Phase 4 study, sponsored by Primus Pharmaceuticals.
NCT06348303 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
NCT06348303, 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 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.
Primary Outcome
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.
Interventions
- DRUG Metaxalone m640 mg oral tablet
- DRUG Metaxalone 800 mg oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2024-10-30 |
| Phase | Phase 4 |
What the finished NCT06348303 record still lists
NCT06348303 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 mg oral tablet is the first listed.
NCT06348303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06348303 about?
NCT06348303 is a clinical study titled "Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg". 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 ...
What is the current status of trial NCT06348303?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-05-16. Estimated completion is 2024-10-30.
What interventions are being tested in trial NCT06348303?
The interventions under investigation include: Metaxalone m640 mg oral tablet (DRUG), Metaxalone 800 mg oral tablet (DRUG).
Who is sponsoring clinical trial NCT06348303?
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 NCT06348303'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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