Metaxalone for Side Effects Study

PM
CM
Overseen ByClinical Manager
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different doses of the muscle relaxant metaxalone to compare their side effects and effectiveness. Participants will take one dose, undergo testing, wait a week, and then take the other dose for further testing. The trial aims to determine which dose better manages muscle pain with fewer side effects. Healthy adults weighing at least 120 pounds, without sleep disorders or substance abuse histories, might be suitable for this trial. As a Phase 4 trial, metaxalone is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

What is the safety track record for Metaxalone?

Research has shown that metaxalone is generally safe when used as directed, though it can cause side effects. Common side effects include dizziness, drowsiness, and nausea, which may intensify if taken with food. Some individuals have also reported headaches and upset stomachs. Serious reactions are rare but can occur, particularly when combined with substances like alcohol that affect the brain. Overall, metaxalone is considered well-tolerated, but awareness of these potential side effects is important. If any symptoms are severe or persistent, consulting a doctor is crucial.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about metaxalone as a treatment for side effects because it offers a novel approach compared to standard muscle relaxants. Unlike typical treatments, which often act on the central nervous system, metaxalone is believed to target muscle pain directly with fewer sedative effects. This could mean improved pain management with less drowsiness, making it a potentially more suitable option for those who need to remain active and alert while managing their symptoms.

What evidence suggests that this trial's treatments could be effective?

Research has shown that metaxalone works well as a muscle relaxant and is often used to ease pain or discomfort from muscle injuries. Studies have found that it helps lessen muscle spasms and improves movement. However, metaxalone may cause side effects such as dizziness, drowsiness, and headaches. These side effects are usually mild but can become more noticeable when the drug is taken with food. Overall, metaxalone is considered effective for treating muscle-related pain and discomfort.

In this trial, participants will receive either a 640 mg or 800 mg dose of metaxalone to evaluate its side effects when administered after a standard meal.12678

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any medical conditions or take medications that could interfere with the study. Participants should be able to safely take metaxalone and complete all testing procedures.

Inclusion Criteria

Able to sign and date informed consent form
Weigh at least 120 pounds
I am a healthy adult between 18 and 55 years old.
See 1 more

Exclusion Criteria

Difficulty eating high fat meal
Heart Rate greater than 100 or less than 50 beats per minute
Known history of alcohol use disorder
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Phase 1

Participants take a single dose of Metaxalone 640 mg after a meal, followed by testing for drowsiness, fall risk, and EEG monitoring

1 day
1 visit (in-person)

Washout

Participants undergo a washout period to clear the first dose from their system

1 week

Treatment Phase 2

Participants take a single dose of Metaxalone 800 mg after a meal, followed by testing for drowsiness, fall risk, and EEG monitoring

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Metaxalone

Trial Overview

The study tests two different doses of metaxalone (640 mg and 800 mg) in healthy people, given after a meal. Researchers will monitor drowsiness, fall risk, and brain activity using EEG after each dose.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Active metaxalone m640 mgActive Control1 Intervention
Group II: Active metaxalone 800 mgActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Primus Pharmaceuticals

Lead Sponsor

Trials
22
Recruited
2,400+

AMR Clinical

Collaborator

Citations

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