Pure Global
NCT06348303

Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg

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
Primus Pharmaceuticals·Phase 4·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Participants
Drug/Device/Intervention
Metaxalone m640 mg oral tablet
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Primus Pharmaceuticals
Location
Columbus, United States of America
Timeline & enrollment
Phase
Phase 4
Start date
Mar 15, 2024
End date
Mar 15, 2025
Enrollment
20 participants
Primary outcome

Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).,Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path,Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path

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.

ICD-10 classifications
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulHealthy person accompanying sick personRoutine general health check-up of sports teamsObesityPersons with potential health hazards related to communicable diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06348303
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06348303 through Pure Global AI's free database. This Phase 4 trial is sponsored by Primus Pharmaceuticals and is currently Recruiting. The study focuses on Healthy Participants. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.