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

Cognitive Impairment Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382662
• Other study ID #: PMDAC-01
• Status: Recruiting
• Phase: Phase 4
• Start date: April 15, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: April 2024
• Source: Primus Pharmaceuticals
• Contact: Medical Director, Primus
• Phone: 480-483-1410
• Email: jlukban[@]primusrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Drug:
• metaxalone m640
A single dose of micronize metaxalone 640 mg
• tizanidine
A single dose of tizanidine 8 mg

Locations

Country	Name	City	State
United States	Sun Valley Arthritis Center	Peoria	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Primus Pharmaceuticals	Sun Valley Arthritis Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change from baseline of participants' subjective report of drowsiness on a 10-point scale	Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake	Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
Secondary	Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test)	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.	Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
Secondary	The number of product related adverse events experienced by participants from Visit 1 through Visit 4	Adverse and Serious Adverse Events	Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15)