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Completed

NCT Number: NCT06382662

Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition

Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sun Valley Arthritis Center

Peoria, Arizona, 85381, United States

About this study

Every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit.

The Screening Visit will be followed by the Baseline (Visit 1) 1-14 days later. At the Baseline Visit participants will be given written tests to measure thinking process. You will also be asked to take a computer driving simulation test.

Visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. The testing from the Baseline Visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug.

The End of Study safety visit will take place two (2) weeks later. Participants will be given discharge instructions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • equal to or greater than 20 years old
  • weight at least 120 pounds
  • medically healthy
  • able to eat a high fat meal

Exclusion criteria

  • medications known to affect sleep-wake cycle
  • current use of cimetidine
  • current use of certain anti-depressants
  • current us of certain antibiotics
  • positive urine drug test for mind altering medications

Treatment and study plan

metaxalone m640

Drug

A single dose of micronize metaxalone 640 mg

Other names: Metaxalone 640

Tizanidine

Drug

A single dose of tizanidine 8 mg

Other names: Zanaflex

Primary outcomes

  1. Change from baseline, Standard Deviation of Lateral Position

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

    Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software

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

    Time frame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)

    Creyos Cognitive Test

Secondary outcomes

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

    Time frame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)

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

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

    Time frame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (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.

  3. The number of product related adverse events experienced by participants from Visit 1 through Visit 4

    Time frame: Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15)

    Adverse and Serious Adverse Events

Sponsors and collaborators

Lead sponsor

Primus Pharmaceuticals

Industry

Collaborators

  • Sun Valley Arthritis Center

Registry information

Official study title

Assessment of the Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Tizanidine 8 mg: A Prospective, Single-blind, Within-subject Pilot Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
Aug 22, 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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