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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 is a Phase 4 study that has completed, run by Primus Pharmaceuticals. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06348303
The ClinicalTrials.gov registry entry for NCT06348303 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Primus Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Metaxalone m640 mg oral tablet is the first listed.
NCT06348303 reports 0 study locations.
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.
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