Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 55

Testing two doses of a muscle relaxant for drowsiness in healthy adults

Official title: A Prospective, Randomized, Single-blind, Study to Assess Drowsiness, Cognition, Fall Risk, and Electroencephalographic (EEG) Dynamics After Oral Metaxalone Tablets 640 mg (M640) Versus Metaxalone 800 mg in Healthy Participants

Run by Primus Pharmaceuticals · NCT07801066 · Data updated 2026-11-12

This study tests two single doses of metaxalone in healthy adults to see how drowsiness and fall risk change when the drug is highest in the blood.

More Healthy Adult Participants trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment20 (estimated)
SponsorPrimus Pharmaceuticals
Industry-sponsored
Locations1 site (Columbus, Ohio)
StatusRecruiting
StartedOctober 15, 2026
Main results expectedJanuary 15, 2027
Study endsJanuary 15, 2027
Registry record updatedNovember 5, 2026
Trial IDNCT07801066 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adults aged 18–55 who weigh at least 120 pounds and have no medical conditions affecting sleep, cognition, or cardiovascular status.

Probably not a fit

Individuals with sleep disorders, cognitive disorders, uncontrolled blood pressure or heart rate issues, or those who are pregnant or taking medications affecting sleep may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy adults will take one dose after a meal, undergo drowsiness and fall-risk testing at peak blood levels, and have EEG monitoring during testing. After a one-week washout, they will receive the second dose with the same testing sequence for comparison. The trial is a randomized, crossover-like comparison of two dosages, conducted at a single site.

Why it matters

Potential benefit: Participants may gain a better understanding of how the two doses affect drowsiness and fall risk, which could inform safer use of the medication.

How similar studies have gone: Previous investigations have examined dose-related drowsiness with muscle relaxants, supporting the feasibility of this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • AMR Clinical - Columbus
    Columbus, Ohio, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.