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Skeletal Muscle Relaxant

metaxalone m640 mg for Cognitive Impairment

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

Weight at least 120 pounds

Equal to or greater than 20 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, visit 2 (day 0), visit 3 (day 1), visit 4 (day 8), visit 4 (day 15)

Awards & highlights

Study Summary

"This trial involves two stages where participants will receive the study drug and a comparator after a high fat meal. Vital signs and discussions about medications, illness, or injury will be assessed at each of the four

Who is the study for?

This trial is for individuals who experience muscle weakness (hypotonia) and may have cognitive impairments. Participants should be able to attend four visits, take the study drug after a high-fat meal, and discuss their health status at each visit.Check my eligibility

What is being tested?

The trial is testing the effects of Metaxalone 640 mg on truck driving ability and cognition compared to Tizanidine. Each participant will try both drugs in two stages, with each drug taken once post-meal.See study design

What are the potential side effects?

Possible side effects might include drowsiness, dizziness, headache, nervousness or irritability which are common with muscle relaxants like Metaxalone and Tizanidine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weigh at least 120 pounds.

Select...

I am 20 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, visit 2 (day 0), visit 3 (day 1), visit 4 (day 8), visit 4 (day 15)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, visit 2 (day 0), visit 3 (day 1), visit 4 (day 8), visit 4 (day 15)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, visit 2 (day 0), visit 3 (day 1), visit 4 (day 8), visit 4 (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 participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes

Change from baseline, Standard Deviation of Lateral Position

Secondary outcome measures

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

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

The number of product related adverse events experienced by participants from Visit 1 through Visit 4

Trial Design

2Treatment groups

Active Control

Group I: metaxalone m640 mgActive Control1 Intervention

metaxalone micronized 640 mg tablet, single dose at Visit 2 or Visit 3

Group II: tizanidine 8 mgActive Control1 Intervention

tizanidine 8 mg tablet, single dose at Visit 2 or Visit 3

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Primus PharmaceuticalsLead Sponsor

21 Previous Clinical Trials

2,336 Total Patients Enrolled

Sun Valley Arthritis CenterUNKNOWN

J C Lukban, DOStudy DirectorSponsor GmbH

Frequently Asked Questions

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

Are individuals older than 40 years eligible to participate in this trial?

"Subjects interested in participating must be aged between 20 and 70 years to meet the enrollment requirements for this study."

Answered by AI

For which individuals is participation in this research study deemed appropriate?

"Individuals aged between 20 and 70 years with cognitive deficits are eligible to participate in this study, which has a capacity of admitting up to 20 participants."

Answered by AI

What is the overall count of individuals participating in this clinical study?

"Indeed, the information available on clinicaltrials.gov confirms that this research study is actively seeking individuals to participate. The trial was originally posted on April 15th, 2024 and underwent its most recent update on April 20th, 2024. The investigators aim to recruit a total of 20 participants from one designated site."

Answered by AI

Has metaxalone at a dosage of 640 milligrams been given the stamp of approval by the Food and Drug Administration?

"Based on our evaluation at Power, metaxalone 640 mg has been rated as a level 3 in terms of safety. This rating is attributable to the Phase IV nature of this trial, indicating that the treatment has already received approval for use."

Answered by AI

Are potential participants still able to apply for enrollment in this ongoing research study?

"According to75.0% confidence level, the clinical trial posted on 4/15/2024 is actively seeking participants as per information available on clinicaltrials.gov which was last updated on 4/20/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants

2024. "Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06382662.

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