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OpenTrials
Completed

NCT Number: NCT06348303

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ClinOhio Research Institute

Columbus, Ohio, 43213, United States

About this study

The Screening-Baseline Visit will include vital signs and urine testing, and a discussion of medications and current medical history. Participants 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.

Visit 2 approximately one to two (1 to 2) week(s) later will be the first dosing day (Arm 1) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.

Visit 3 approximately one (1) week later will be the second dosing day (Arm 2) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.

The End of Study safety visit will take place one (1) week after Visit 3 by phone with a discussion of any side effects from the drug, recent medications, and any illness or injury experienced since the previous visit. Participants will be given end of study and discharge instructions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Metaxalone m640 mg oral tablet

Drug

Metaxalone partially micronized 640 mg tablet

Other names: m640

Metaxalone 800 mg oral tablet

Drug

Metaxalone non-micronized 800 mg oral tablet

Other names: Skelaxin

Primary outcomes

  1. Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test).

    Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)

    Validated 4-Stage Balance Test after completion of an FDA standardized high-fat meal. Place one foot in front of the other, heel touching toes.

  2. Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path

    Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)

    Timed Up and Go with Triaxial Accelerometry

  3. Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path

    Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)

    Tandem Walk Test

Secondary outcomes

  1. Change from baseline of participants' subjective report of drowsiness on a 10-point scale

    Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)

    Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake

  2. Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds

    Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)

    Reaction Time Test (RTT)

  3. Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes

    Time frame: Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8)

    Creyos Cognitive Test

  4. The number of product related adverse events experienced by participants from Visit 2 through Visit 4

    Time frame: Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15)

    Adverse and Serious Adverse Events

Sponsors and collaborators

Lead sponsor

Primus Pharmaceuticals

Industry

Collaborators

  • ClinOhio Research Services, LLC

Registry information

Official study title

A Prospective, Randomized, Single-blind, Pilot Study to Assess Drowsiness, Cognition, and Fall Risk Following Oral Metaxalone 640 mg (M640) Versus Metaxalone 800 mg in Healthy Subjects"

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2024
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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