Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg

Completed · Phase 4

Conditions studied: Healthy Participants

In brief

Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.

Key facts

Study ID: NCT06348303
Run by: Primus Pharmaceuticals
People needed: 20
Starts: 2024-05-16
Expected to finish: 2024-10-30
Last updated by the study team: 2025-08-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Weigh at least 120 pounds at Screening
Medically healthy with no clinically significant medical co-morbidities impact endpoints

You may not qualify if…

Current use of any medications known to affect sleep-wake cycle.
Known sleep disorder.
Current use of cimetidine.
Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5- hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol).
Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids.
Participants taking skeletal muscle relaxants or sedative hypnotics.
Participants with gastrointestinal disease affecting absorption.
Participants with severe hepatic or renal impairment.

Where it is running

ClinOhio Research Institute — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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