Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg - Trial NCT06348303
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.
Study Focus
Sponsor & Location
Primus Pharmaceuticals
Timeline & Enrollment
Phase 4
Mar 15, 2024
Mar 15, 2025
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
Data Source
ClinicalTrials.gov
NCT06348303
Non-Device Trial