Can a lower dose of a muscle relaxant keep people steadier on their feet?
NCT ID NCT07801066
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests two doses of the muscle relaxant metaxalone, 640 mg and 800 mg, in healthy adults aged 18 to 55. After taking each dose with a meal, researchers measure drowsiness, reaction time, and brain wave activity to assess fall risk. Each participant takes both doses one week apart, and the study compares the effects. The goal is to see if the lower dose might cause less sleepiness and better balance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- metaxalone (a muscle relaxant) at two doses: 640 mg and 800 mg
- What this could lead to
- If it works, this could help doctors choose a safer dose of metaxalone that causes less drowsiness and fall risk.
- What could go wrong
- This is a small, early-stage trial in healthy people, so results may not apply to patients. The drug may still cause drowsiness at either dose.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy adults aged 18 to 55 years old * Weigh at least 120 pounds * Medically healthy * Able to sign and date informed consent form Exclusion Criteria: * Current use of any medications known to affect the sleep-wake cycle * Sleep disorder diagnosis * Positive urine test for drugs * Known history of alcohol use disorder * Having a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia * Having difficulty eating high fat meal * Participants who are pregnant, nursing or intending to become pregnant during the period of study. * Blood Pressure \> 160/110 or \<90/50 mmHg. * Heart Rate \>100 or \< 50/ beats per minute. * Having a history of seizure disorder or epilepsy.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AMR Clinical - Columbus
Columbus, Ohio, 43213, United States