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Muscle Relaxant

Active 640 mg for Healthy Subjects

Phase 4

Recruiting

Research Sponsored by Primus Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 2 dosing (day 1, visit 3 dosing (day 8), visit 4 end of study (day 15)

Awards & highlights

Study Summary

This trial involves giving participants Metaxalone in two stages, one week apart, after a high-fat meal. Participants will undergo tests to measure drowsiness, reaction time, and thinking abilities, as

Who is the study for?

This trial is for healthy individuals experiencing excessive daytime sleepiness. Participants will be involved in the study for about 2-4 weeks, taking Metaxalone after a high-fat meal and undergoing tests to assess drowsiness, cognition, and fall risk.Check my eligibility

What is being tested?

The study is testing two doses of Metaxalone (640 mg and 800 mg) taken orally. Each participant will try both doses in separate stages to compare their effects on drowsiness, cognitive function, and balance.See study design

What are the potential side effects?

Potential side effects from Metaxalone may include dizziness, headache, nausea or vomiting, nervousness or irritability; these could impact alertness and coordination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 2 dosing (day 1, visit 3 dosing (day 8), visit 4 end of study (day 15)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 2 dosing (day 1, visit 3 dosing (day 8), visit 4 end of study (day 15)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 dosing (day 1, visit 3 dosing (day 8), visit 4 end of study (day 15) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path

Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path

Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).

Secondary outcome measures

Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes

Change from baseline of participants' subjective report of drowsiness on a 10-point scale

Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Active 640 mgActive Control1 Intervention

Metaxalone (M640) 640 mg tablet, a single-dose at visit 2 of 4 visits.

Group II: Active 800 mgActive Control1 Intervention

Metaxalone 800 mg tablet, a single-dose at Visit 3 of 4 visits.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ClinOhio Research Services, LLCIndustry Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

Primus PharmaceuticalsLead Sponsor

21 Previous Clinical Trials

2,336 Total Patients Enrolled

J Lukban, DOStudy DirectorPrimus Pharmaceuticals, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria are used to determine eligibility for participation in this medical study?

"In order to qualify for this research study, individuals must be deemed healthy and fall within the age range of 18 to 45 years old. The goal is to recruit a cohort of 20 participants in total."

Answered by AI

Are individuals older than 45 years eligible to participate in this study?

"Individuals aged between 18 and 45 are eligible for this study as per the inclusion criteria. There are a total of 73 trials tailored for participants under 18 years old, alongside an additional 400 studies designed specifically for individuals above the age of 65."

Answered by AI

What is the current number of participants under observation in this clinical investigation?

"Indeed, the details on clinicaltrials.gov suggest that this trial is presently enrolling participants. The study was first listed on 3/15/2024 and last revised on 3/30/2024. Enrollment is open for 20 individuals at a single location."

Answered by AI

Has the Active 640 mg received approval from the FDA?

"Our team at Power has assessed the safety of Active 640 mg as a score of 3 on the scale. This high rating is due to it being part of a Phase 4 trial, indicating that this treatment has already received regulatory approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06348303.