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

NCT06382662 | Completed Phase 4 FDA Drug

• 1 other identifier: PMDAC-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment

Keywords

Impaired driving

Outcome Measures

Primary Outcomes (2)

• Change from baseline, Standard Deviation of Lateral Position

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

  Baseline, Visit 2 dosing, (day 1), Visit 3 dosing, (day 8)

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

  Creyos Cognitive Test

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

Secondary Outcomes (3)

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

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

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

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

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

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

Study Arms (2)

metaxalone m640 mg

ACTIVE COMPARATOR

metaxalone micronized 640 mg tablet, single dose at Visit 2 or Visit 3

Drug: metaxalone m640

tizanidine 8 mg

ACTIVE COMPARATOR

tizanidine 8 mg tablet, single dose at Visit 2 or Visit 3

Drug: tizanidine

Interventions

metaxalone m640 DRUG

A single dose of micronize metaxalone 640 mg

Also known as: Metaxalone 640

metaxalone m640 mg

tizanidine DRUG

A single dose of tizanidine 8 mg

Also known as: Zanaflex

tizanidine 8 mg

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Primus Pharmaceuticals: lead
• Sun Valley Arthritis Center: collaborator

Study Sites (1)

Sun Valley Arthritis Center

Peoria, Arizona, 85381, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

tizanidine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• J C Lukban, DO

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) compared to tizanidine 8 mg in healthy subjects.

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 24, 2024
• Study Start: April 29, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 6, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)