Healthy Participants Will Take One Dose of a Drug After Eating a Meal, Then Test for Drowsiness and Fall Risk With Brain Wave Monitoring Throughout the Testing. Participants Will Take a Second Dose of the Drug With the Same Testing.

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07801066

Enrollment

Registered

2026-09-03

Start date

2026-09-15

Completion date

2027-01-15

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison Between 2 Doses of Metaxalone to Measure Drowsiness, Cognition and Fall Risk

Keywords

healthy participants tested for drowsy, thought and fall risk

Brief summary

Healthy participants will take one dose of a drug after eating a meal. When the drug is at the highest level in their blood, testing for drowsiness and the risk of falling will take place. Brain wave monitoring known as an EEG will take place throughout the testing. Participants will take a second dose of the drug with the same testing one week later.

Interventions

DRUGMetaxalone 640 mg

Dose micronized 640 mg

DRUGMetaxalone 800 MG

The dose is 800 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline to approximately 4 hours post-dose, in mean reaction time to a stimulus as measured in milliseconds by the Reaction Time Test (RTT)	Baseline dose to four (4 ) hours post-dose
Change from baseline to approximately 4 hours post-dose of delayed response exceeding a predefined threshold >300 ms as measured by the Reaction Time Test (RTT)	Baseline dose to approximately 4 hours post-dose

Countries

United States

Contacts

CONTACTProject Manager

mshahbandar@primusrx.com480-483-1410

CONTACTClinical Manager

msanstead@primusrx.com480-250-6689

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026