Clinical trial NCT06382662: Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cognitive Impairment
Keywords: Impaired driving
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sun Valley Arthritis Center
First posted: 2024-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline, Standard Deviation of Lateral Position
timeFrame: Baseline, Visit 2 dosing, (day 1), Visit 3 dosing, (day 8)
measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes
timeFrame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
Secondary outcomes:
measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale
timeFrame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test)
timeFrame: Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8)
measure: The number of product related adverse events experienced by participants from Visit 1 through Visit 4
timeFrame: Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15)
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Sun Valley Arthritis Center
state: Arizona
Study officials:
affiliation: Sponsor GmbH
name: J C Lukban, DO
role: STUDY_DIRECTOR
References: